[posted via Justice in Michigan]

Two Anti-preemption Groups Unite

For release, April 20. 2009

 

Americans for Drug and Device Accountability (ADDA) and Justice in Michigan (JIM) have announced their consolidation into a single organization dedicated to fighting FDA preemption in the drug and device arenas, and on both the state and national levels.  Their updated website is http://pharmaccountability.org/.

 

ADDA was formed one year ago and consists of business people, patient advocates, healthcare professionals, and concerned citizens.  Members represent the full political spectrum—from conservative Republicans to liberal Democrats.  They also include current and former employees of the pharmaceutical industry who agree that FDA preemption is bad policy—a disaster for patient rights, public health, and industry accountability.  A petition initiated last year quickly gathered nearly 1,000 signatures and comments, including those of Dr. David Graham of FDA, Dr. Joel Lexchin, Dr. Doug Bremner, Dr. Howard Brody, Vera Sharav, Tom Lamb, and many more.

 

JIM was formed four years ago, primarily by social scientists, policy analysts, and bioethicists in Michigan.  Along with issues of healthcare and social justice generally, the organization’s focus has been on Michigan’s unique drug industry shield law, passed in 1996, that fully bars Michigan citizens from bringing suit over drugs approved by the FDA.  Michigan’s law is the most draconian in the nation.  Courts have ruled that even the most egregious negligence or fraud would not open the courthouse to Michigan citizens.  That is thirteen years of justice denied.

 

Both ADDA and JIM believe that it will take legislative action to restore justice.  On the national level, this means the Medical Device Safety Act which would restore the right of citizens to bring suit in the medical device arena.  In Michigan, it means rescinding drug industry immunity.  The Michigan House has already voted twice to do so.  But the bills have been killed by a small number of immunity supporters in the Michigan Senate.

 

The national and state levels of these issues reinforce each other.  Across both parties, and across this land, citizens are recognizing that the days of special interest legislation—along with the era of government arrogance and irresponsibility—are drawing to a close.  Before long, we will look back at this time as a nightmare from which we will be thankful to have awakened.  In the meantime, Americans for Drug and Device Accountability and Justice in Michigan fight toward that dawn.

 

Join us.

 

http://pharmaccountability.org/

 

“Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness” – Justice John Paul Stevens

In this week’s bmj there is an article by Thomas Jefferson of the Cochrane Vaccine Institute (”Relation of study quality, concordance, take home message, funding, and impact in studies of influenza vaccines: systematic review“) whom I have often quoted before (”Flu Shots are for Idiots“) regarding the dubious evidence behind policy recommendations regarding flu shots. Now he presents data that studies of flu shots funded by pharmaceutical companies are more likely to be published in prestigious journals than those funded by other sources, in spite of the fact that they have the sample sample size and comparable methodology. He goes on to write:

The study shows that one of the levers for accessing prestige journals is the financial size of your sponsor. Pharmaceutical sponsors order many reprints of studies supporting their products, often with in-house translations into many languages. They will also purchase publicity space on the journal. Many publishers openly advertise these services on their website. It is time journals made a full disclosure of their sources of funding.

A position supported by the staff at Drug Safety and Health News. He goes on to discuss the “impact factor”, a metric related to how many times other authors of journal articles cite you in their articles, which is supposed to be a measure of how good or important your study is. However there is a tendency to cite articles in the big journals like JAMA or New England Journal of Medicine just because we all think that if they got in there they must be really good. What this does is give an advantage to those physicians and researchers who are doing the clinical trials funded by pharma, makes them more cited, enhancing their prestige, and hence even more valuable to their pharma friends. Soon everyone is wining and dining, have a good time, and making more money all around.

 

But you can see how this has a corrupting influence on the practise of medicine. As pointed out in a letter to the editor of Houmatoday.com in Terrabonne Parish, Louisiana, by Dr. Randolph M. Howes (”Death by Peanut Butter or Drugs?”) 50% more people die of prescription drugs every hour than have collectively died from peanut butter.

Hat tip to Dan Abshear.

An article from the Jan. 3 2009 issue of The Lancet used a meta analysis to show that so-called first generation antipsychotics (FGAs) and second generation antipsychotics (SGAs) are not that much different in terms of efficacy, safety, and side effect profiles. The purported superiority of SGAs for negative symptoms and fewer side effects for SGAs were primarily the results of comparator studies that put them up against high dose haloperidol.

I have been reading a book called Hooked: the Medical Profession and the Pharmaceutical Industry by Howard Brody, MD PhD, of the University of Texas, Galveston, which I highly recommend as an interesting book that adds a lot even for those of you who feel you are “read out” on this topic, and this episode of comparing new drugs to old drugs given at doses that cause more side effects without providing more efficacy (which is stacking the deck in favor of the new drugs) is a pharmaceutical industry tactic that he identifies, although this is the first time we have heard of it as applied to antipsychotic “life saving drugs”.

Psychiatrists moved en masse from the FGAs to the SGAs largely because of concerns about tardive dyskinesia, extra pyramidal side effects, and what may have been a misguided belief that these drugs worked better, fueled by pharmaceutical marketing. As the paper shows, most studies in the literature were found to be using high dose haloperidol (>7.5 mg/day) (Haldol) as the comparison drug, which biased the trials in favor of showing a better side effect profile for the newer drugs. When studies using lower potency first generation drugs were focused on, the differences in safety and efficacy were considerably diminished. Specifically, the SGA drugs as a whole were not seen to be specifically better for negative symptoms of schizophrenia, which does not support marketing claims to the contrary. The drugs that were better for negative symptoms were also equally better for positive symptoms and depression. Although clozapine, olanzapine, and risperidone were marginally better for extra pyramidal side effects, which is largely why psychiatrists moved so heavily into SGAs in the first place, the effects were not large, and there were no significant differences for the other SGAs. The only SGAs that were shown to be better for psychotic symptoms than low dose FGAs were amisulpride (Solian, Sultopride), clozapine (Clozaril), olanzapine (Zyprexa) and risperidone (Risperdal). These drugs, however, caused more weight gain than haloperidol (but not low potency FGAs). Only Amisulpride and sertindole (Serlect) were better for quality of life. Aripiprazole (Abilify) was only better for depression and quetiapine (Seroquel) was better for positive symptoms and depression. Sertindole (Serlect), ziprasidone (Geodon), and zotepine (Zoleptil) were not better for any symptom area.

The recent CATIE study compared SGAs to the FGA perphenazine (Trilafon), and found that most of them were not better for efficacy or side effects, only olanzapine had a longer time to discontinuation (the primary outcome) and clozapine was better for symptoms. However, clozapine has bothersome blood monitoring requirements because of the risk of aplastic anemia, and olanzapine has some worrisome diabetes risks. What was most amazing about the CATIE study, however, was the fact that half of people stopped taking their meds after a couple of months, which indicates that people feel really lousy on these drugs.

The article was accompanied by an editorial by Turner and Horton entitled “The Spurious Advance of Antipsychotic Therapy” in which the authors said that psychiatrists had been “beguiled” (presumably by the pharmaceutical industry) into believing that the SGAs were superior (a point highlighted by others like Vera Sharav of the Alliance for Human Research Protection (AHRP). Although I wouldn’t agree with the emphasis that there is no difference between these drugs, it is true that the safety and efficacy of these drugs have been greatly distorted, that we should stop using the distinction of SGA-FGA or talking about unique profiles of “atypicals”. In addition, It is unclear if the extra cost of these drugs justifies their use when there is an increased risk of obesity and diabetes with not that great of an advantage for extra pyramidal side effects. Certainly for the drugs not better than low potency FGAs there is not.

Guess we got duped by pharma. Yet again.

Sigh.

originally posted jan 12 2009

This has been quite a year for disturbing revelations about the corruption of the medical literature by pharmaceutical company interests. I wrote previously about ghost writing by Merck and others, and how papers were produced by drug companies that said “insert author here” and then they went out and shopped around for an author at an academic institution. Academics are always worried about damage to their reputations, but in these cases, what can your say…?

I previously wrote about a study showing that the overwhelming majority of negative trials never get published while the positive ones always do, which leads to a false sense of the efficacy of the drug. The worst extreme of course is the sorry example of trials of SSRIs in kids where multiple studies of paxil were “shoved in the desk drawer” as we say here in the industry, and a bs campaign to get kids on paxil was launched.

In the study I previously wrote about on suppression of the literature on antidepressants if you only looked at the medical literature, you would think that 94% of the studies show that antidepressants work, when in fact only 51% were positive.

I remember a couple of years ago standing at a poster with a glass of wine in my hand at the American College of Neuropsychopharmacology (ACNP) which presented similar data (maybe it was the same study). Someone from pharma commented that you can’t get negative data published. Well that is a lot of hooey. You can get data published somewhere. For instance, Psychopharmacology Bulletin, where I am an Associate Editor (at least for now), and that publishes its stuff online, makes a policy of taking in negative clinical trials.

In this week’s NEJM there is an editorial about the promotion of Neurontin (gabapentin) for off label uses ranging from bipolar disorder to neuropathic pain. This editorial includes references to online documentation of how data was suppressed and manipulated, marketing tactics were used to illegally promote off label use, and academics, government, and the FDA either colluded or did nothing. Other news comes from an article by Ray Moynihan in bmj showing that the pharmaceutical industry has used a strategy of “grooming” the Key Opinion Leaders (KOLs) (their terms, not mine) to promote their “message”, and how they measure prescribing practices before and after a “KOL” gives a talk to check their impact on local prescribing practices, and then reward “good” KOLs with more talks with lucrative speaking fees and “drop” under performers. Of course this unconsciously drives speakers to push their product. I for one went through this mill back in 2001 and was probably dropped for not performing and arguing with them about using their slides. I gave a talk last year for grand rounds at a med school and a friend of mine told me I was not “approved” by the drug company sponsors and therefore they had to scramble to find funds to pay for talk. More news from the bmj article is that there are organizations that offer to “manage” your “KOLs”, like kolonline.com. You can read for yourself, but they basically offer their services to drug companies to manipulate or control KOLs to deliver the “right” message to the other docs who will follow their lead about how to prescribe. They offer to “validate and manage” the KOLs and “identify rising stars” (sounds like grooming young girls to participate in prostitution and/or incest to me). Disgusting. Can you say…?

To comment on this blog please write to jamesdouglasbremner@yahoo.com and indicate whether comments are public or private.

originally posted Jan 8, 2009

COMMENTS

Doug, You may want to look up the settled qui tam false case act: David Franklin v. Parke Davis (Pfizer). Franklin was with Parke Davis while selling Neurontin, and he filed this case in 1996. It settled in 2004. He was a Harvard PhD, and working as a medical laison for them for maybe 3 or 4 months, and was being coerced to do things you illustrated in your post, Dan

---

Yes, there was a whistle blower cited in the article I linked to, I think it was the same one. His boss told him to sell Neurontin for everything. Put today (look here there is an article in the NYT that the FDA approved companies to promote off label use. Dreadful. Why is the FDA even there? -Doug Bremner

---

I wrote a blog post about Neurontin being no better than a placebo for bipolar treatment. Sounds like this drug is a junker–and used for pain far too often and then it can cause psychosis and weird stuff in medical patients. Stephany

http://bipolarsoupkitchen-stephany.blogspot.com/2008/04/neurontin-vsplacebo-for-bipolar.html

Update: article by former Yale Psychiatry resident Jeff Barkin MD on lack of efficacy of Neurontin for bipolar disorder and Pfizer’s fraudulent campaign to promote it for thie use. Other litigation reports and documents at the same web site.

I remember one time sitting out on the deck of my family’s house on Puget Sound talking to my father and my brother and telling them that the people in academic psychiatry didn’t have a sense of humour and they told me I should work in a different field. That seemed extreme to me at the time but in retrospect I think they were probably right. That is why I am saddened to have lately written such boring and unhumorous posts as my responses to the ACNP and others in which I didn’t use any humour in order to not piss them off any more than they are already.

A lot of people have written to me saying that I had “courage” or similar things to express things directly. Fact is that academics take themselves too seriously, don’t have a sense of humour, emphasize loyalty, and live in fear of their colleagues and of various outside forces. Come to think of it, it reminds me alot of the mafia from my wife’s native Sicily. Like them, academics are a group that share in common something to hide, namely large payments from pharmaceutical companies that they privately justify as payment for services in drug development but that they nevertheless don’t want to be publicly known.

Psychiatrists generally attribute criticism to scientologists or anti-psychiatrists and use that tactic to blow them off but my colleagues in medicine just go with a sense of self entitlement. One of the readers of the Drug News and Health Safety Blog was a physician in another department at Emory who complained that he went to his computer every morning and got an email called “Before You Take That Pill”. He also complained that the publicity over pharma payments to physicians threatened his ability to get income from giving lectures funded by the pharmaceutical industry. So I just took him off my email list and he is happy now. Reminds me of a psychiatry consult I once did on an inpatient who had a heart attack and was depressed. He was obsessing about a picture in a heart education book they had given him that had a diagram of how a blood clot had obstructed a coronary artery. My “treatment” was to tear the page out of the book. Worked wonders.

I have been reading a book about the relationship between the pharmaceutical industry and academic medicine and I am coming to the conclusion that ANY so-called education funded by pharma is suspect, and that physicians should go back to the old system of paying for their own god damn education. Or read a book for Christ’s sake.

Anyhoo I digress and as usual I forgot what I was talking about. Oh, yes. Lolcats. Lolcats are always there to come to the rescue when we lose our sense of humour or get an exaggerated view of ourselves. Lisa Van Syckel told me that the quote from Senator Charles Grassley (R-Iowa) is: “If you swing a cat around by the tail you will hit someone from the pharmaceutical industry.”

I had to puzzle over that for a while like one of the Koans that my beloved deceased mother used to enjoy and had to ask Lisa what that meant.

“Well it just means that there are a lot of people in the pharmaceutical industry”

Sometimes things that are true are also so simple that you can’t recognize it if it is right in front of your face. What was your face before you were born?

I have been mulling over that this week, as well as the effects of pharmalot withdrawal, which has been under consideration as a new psychiatric disorder by our DSM V Shadow Team. Related to that in an interview after the closure of pharmalot with pharmalot’s Ed Silverman by BNET journalist Jim Edwards (who incidentally prompted my post about facebook “Will You Be My Friend?” after he hurt my feelings by asking why I wanted to “friend” him) Ed said that his favorite post was one about Pfizer VP for HR Mary McCleod taking a helicopter to work in Manhattan every week when the rank and file were being laid off and there was cost cutting all around. That prompted a fascinating ongoing string of comments from Pfizer employees and “stockholders” expressing their outrage interspersed with comments from people like Justice in Michigan and Jaynesday saying “Hey look, you have a conscience like us” which they of course ignored. Lisa also told me that when Pfizer employees were protesting outside of corporate headquarters in NJ that they put a giant inflatable rat outside. Here he is at another gig outside the International Longshoreman’s Union in Brooklyn.

Of course that brought to mind Sen. Grassley’s comment so of course I had to photoshop it, and here it is.

DON LET THET RAT LEVE BIFOR A GET THER!

LOL!