INdiana Systemic Thinking

February 16, 2008

FDA: Allowing Big Pharma’s Off Label Advertising

According to the Indianapolis Star this morning, the Food and Drug Administration will continue allowing pharmaceutical companies efforts to market a drug’s “off-label” uses, as long as the companies adhere to certain guidelines.  This “marketing” includes giving physicians articles describing “off-label” use.  In the past this practice has come under fire as the companies themselves sponsored the research and the articles were not published in peer reviewed journals.  According to the new guidelines;

Articles should not be false or misleading and should come from a peer-reviewed journal that is not influenced by the company. The proposal also says companies should attach a disclaimer to the materials indicating that the FDA has not reviewed them.
Drug industry advocates said the proposal firmly establishes FDA’s role as a regulator of medicine — not information.

However, these “advocates” have a lot to gain by the ruling.
Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.

January 27, 2008

Sen. Patricia Miller Dissed by Senate on Ethics

Senator Patricia Miller (R-Indy) is a very, and I cannot underscore that enough, very powerful Senator in the Indiana Senate.  She chairs the Senate Health and Provider Relations committee, and is therefore very influential in all areas of health and healthcare policy for the state.  She is also powerful in other areas.  Some credit her with putting together a coalition that ultimately chose Senate Pro Tempore, David Long, as leader of the Senate.  Therefore, today’s news of the death of her bill to require a cooling off period for legislators (one year) before they can become lobbyists, comes as somewhat of a shock.

Sen. Marvin Riegsecker, the Goshen Republican who controlled the bill’s fate as chairman of the Senate Public Policy Committee, said he killed the proposal because he and other senators were angered by comments that “we’re taking money under the table. That’s the interpretation we had.”

Those members of the public who had pushed for the bill say they were talking about the legislature’s image, not making specific accusations.

“I guess we read between the lines,” Riegsecker said. “Either way, it angered my fellow senators, so I wasn’t going to subject them to a vote. I don’t think the bill would have passed anyway.”
It has elsewhere.

Twenty-six states have enacted one- or two-year cooling-off periods for lawmakers.

In Indiana, more than 30 former lawmakers have registered as lobbyists, including four former speakers of the House.

Supporters of the cooling-off period were optimistic when Miller’s bill was granted a hearing before the Senate Public Policy Committee.

Vaughn said she made sure members of the public came to testify, so lawmakers couldn’t say people didn’t care about such issues.

But, she said, the lawmakers were hostile “from the get-go.”

“To be honest, it almost seemed to me that they wanted to be offended so that they would have an excuse not to deal with the problem,” said Patricia Wittberg, a sociology professor at Indiana University-Purdue University Indianapolis and a Catholic nun, who came to testify.

Wittberg said that throughout her 18 years of teaching, when she talks to her students about legislators representing them “in a fair and just way, and not influenced by special interests, the students laugh. They laugh.”

It was those words that Sen. Vi Simpson, D-Ellettsville, found among the most offensive.
“The testimony was so nasty and mean and personal that the committee members were furious,” she said. “It was a very unpleasant confrontation. That’s not how you get legislation passed around here.”

Sandra Mowell, a member of the League of Women Voters who also testified, said it was lawmakers who were “rather nasty.”

“I thought they just reacted rather violently without a whole lot of provocation toward us,” she said. “People in elective office may say they want people to participate in this process, but I went away with the definite opinion that that’s just talk.”

Miller said she may file the bill again next year.

Senate President Pro Tempore David C. Long, R-Fort Wayne, said the legislature will at some point have to take up the issue.

“I do think we’re going to have to take a hard look at how Indiana compares to other states and ultimately address particularly the issue of how soon you can go out into the hall and lobby,” he said.

Senator Miller is to be congratulated for sponsoring this measure and she is right on track with her reasons for the bill.  Other lawmakers should probably stop taking public comments so personally and realize, as hard as that may be, that the public perception of legislators to lobbyists so quickly looks bad.  In reality, it may not be, but right now there is an angry population out there, and they do vote.  Failing to address this issue looks like legislators are padding their own bank accounts (after they leave) while the rest of us pay more and more in taxes.  Is this a correct perception?  Probably not, but right now perception is reality and legislators would be well advised to realize that.

January 22, 2008

Mid-day Musings: Dems Debate, Lobotomies, Etc.

Last night I was flipping channels between the Democratic debate and a PBS documentary on lobotomies.  Seriously, I was, I’m not just making that up for some punch line.

First, the debate.  Because I was switching channels, I obviously didn’t get to see the whole thing.  BUT WOW!  Can Hillary and Barak be more hateful toward each other?  On one hand it was entertaining to watch…sort of like a schoolyard fight, but on the other hand, has the Democratic party really sunk so low that two out of the three top contenders have to interrupt each other so much that they can’t even carry on a civilized conversation?  Someone needs to remind these two it was a debate, not an argument.  There is a distinction there.  The first is an exchange of ideas with mutual respect where, at the end, two people can agree to disagree.  The second, well, looked a lot like what we had last night.  Oh, and John Edwards didn’t come put looking too good either.  He appeared to agree with whoever had the best “gotcha” or the most applause.  All the time though, never getting his hands dirty.  If I continue with the schoolyard fight analogy, he is the kid in the back, yelling the loudest, but never putting himself out there to either throw a punch or take one in the gut.  Some would say that is smart, but where I went to school we had a rather unflattering name for people who did that.

Next up, Lobotomies.  Wow, what an interesting, if not gut wrenching show from PBS’s American Experience.  Everything anyone wanted to know about the procedure was presented in detail.  I have to admit, at times, I was glad to flip over to the debate as descriptions, pictures, and video were presented about the procedure.  It’s one thing to academically study something from the psychiatric past, but another to have it so blatantly explained.  I’d recommend watching it if your in the field, although ever being confronted with someone who had one is rare nowadays (they aren’t performed anymore).  Luckily, if you follow this link, PBS is promising to allow the show to be viewed online in a few days.

January 21, 2008

Shiney Stuff Gone From Minn. Hospital Network

All I can say is N-I-C-E!

 From WTHR:

When a Duluth-based operator of hospitals and clinics purged the pens, notepads, coffee mugs and other promotional trinkets drug companies had given its doctors over the years, it took 20 shopping carts to haul the loot away.
The operator, SMDC Health System, intends to ship the 18,718 items to the west African nation of Cameroon.

The purge underscored SMDC’s decision to join the growing movement to ban gifts to doctors from drug companies.

SMDC scoured its four hospitals and 17 clinics across northeastern Minnesota and northwestern Wisconsin for clipboards, clocks, mouse pads, stuffed animals and other items decorated with logos for such drugs as Nexium, Vytorin and Lipitor.

Trinkets, free samples, free food and drinks, free trips and other gifts have pervaded the medical profession, but observers say that’s starting to change.

“We just decided for a lot of reasons we didn’t want to do that any longer,” Dr. Kenneth Irons, chief of community clinics for SMDC, said Friday.

So SMDC put together a comprehensive conflict-of-interest policy that, among other things, limits access to its clinics by drug company representatives. Employees suggested the “Clean Sweep” trinket roundup, Irons said.

Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America, had heard of hospitals and clinics banning promotional items before, but said SDMC’s purge was unprecedented.

Read the whole story by clicking the link.

January 20, 2008

Ethics: Inside SB 65, SB 159, & HB 1063

The Fort Wayne Journal Gazette has an editorial this morning regarding three different ethics bills in the legislature.  These bills would place limits, or require reporting, on legislators regarding what they accept and what goes on in the world of lobbying.  Here are the bills:

Senate Bill 59: Reduces from $100 to $25 the minimum reportable amount for total daily gifts to a legislator or a legislative employee given by a registered lobbyist or a single gift received by a legislator or legislative candidate.

Senate Bill 165: Provides that an individual who has served as a member of the General Assembly may not register as a legislative branch lobbyist during the period that ends one year after the date the legislator leaves.

House Bill 1063: Provides that a member of the General Assembly, a candidate for a legislative office, an officer or employee of the General Assembly or a member of the immediate family of any of those individuals may not accept a gift from a lobbyist. Provides that a lobbyist may not give a gift to any of these persons. Provides that violations of any of the prohibitions on giving or accepting gifts is a Class B misdemeanor. Provides that an individual who has served as a member of the General Assembly may not register as a legislative branch lobbyist during the period that ends two years after the date that the individual ceases to be a member.

The article also goes on to state:

The odds aren’t good for the legislation. The Senate lobbying bill, with only a one-year “cooling-off” period, met opposition Wednesday in the Commerce and Public Policy Committee. The committee chairman said the bill needed its own cooling-off period. He didn’t call it for a vote, essentially assigning it to oblivion.

Stricter ethics laws need no more consideration. Legislators who think otherwise should look to the lobbyist scandals in Alaska and Tennessee to see how their own reputations might be tarnished by misdeeds in their midst. They can enhance the General Assembly’s reputation with voters by first approving strict and straightforward restrictions on gifts and lobbying. Then they can get to the hard work of fixing property taxes.

January 6, 2008

APA Elections: Big Pharma’s Candidate

This should scare everyone whether you see a psychiatrist or not.  The practice of “paying” doctors with the unspoken agreement they will prescribe more of a company’s drug is prevalent in all areas of medicine.  Today, Dr. Daniel Carlot, a psychiatrist campaigning against such practices, brings to light ties one of the candidates for the American Psychiatric Association’s presidency has with Big Pharma.

In one corner, we have Donna Norris, M.D., a child and adolescent psychiatrist who has been active in APA governance for 25 years. She is currently the secretary-treasurer of the APA, chair of the Ethics Appeals Board, and a past speaker of the APA Assembly. More to the point, she is concerned about the pharmaceutical industry’s influence on our profession. She chairs a special task force in charge of screening all potential members of the DSM-5 committee for commercial conflicts of interest. On a more personal note, she receives no financial compensation from drug companies, depending on her private practice for all of her income.

By contrast, Alan Schatzberg, M.D., has no APA governance experience, although he once served as vice president of the Northern California Psychiatric Society. Even more troubling, he was involved in what many consider an ethical breach in 2002, when he wrote an article endorsing mifepristone for psychotic depression without disclosing the full extent of his financial involvement in Corcept, the company that has tried to develop the drug for this purpose. At that time he owned 3 million shares; the current value of these shares is about $12 million. Currently, Schatzberg is the editor-in-chief of a journal entitled the “International Journal of Sleep and Wakefulness” which is funded wholly by Cephalon, a pharmaceutical company that sells Provigil. The purpose of this pseudo-journal appears to be to convince readers that sleepiness is a huge public health problem and that Provigil is the mainstay of treatment.

[Blogmeister Note:  DSM-5, referred to above, stands for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.  Currently under development, it is the “Bible” of psychiatric diagnosis and treatment.]

Everyone should be aware of Pharma’s practices in medical treatment.  The Blogmeister would even go so far as to encourage you to ask your physician if they have received ANYTHING from the company who makes the drug you are prescribed (they ethically have to tell you).  If so, you could be prescribed medication that has less to do with your physical condition, than how much they are compensating your physician.

In the spirit of full disclosure, the Blogmeister barely gets paid by insurance companies and patients, let alone Big Pharma.

December 9, 2007

Marketing and Big Pharma

Last night I had finished all the posting work for the blog and decided to do some web surfing.  It dawned on me I hadn’t done much of that since installing the RSS feed software.  So there I went.

However, I was drawn to a memory I had earlier in the day when I was posting this about Eli Lilly hiring a firm to do “damage control” [my phrase] for the drug Zyprexia.  I remember the story quoted a Psychiatrist who ran a blog.  I decided to check it out. 

I don’t know about anyone else, but things tend to trend for me.  What I mean is certain topics come up in different situations a few times over a few days.  This was one of those occasions.  As I looked through Dr. Carlat’s blog I was struck by the number of unflattering posts about the marketing practices of the major pharmaceutical companies.  What was strange, in a Jungian synchronicity way, was I remembered reading a post on Dr. Mike Schatzlein’s blog (titled, Is This Thing On), about the same topic, but more related to physical medicine.  I wasn’t going to post about it, because it didn’t really have anything to do with mental health, but once I read Dr. Carlat’s article, I decided big-pharma’s marketing tactics were relevant to everyone in healthcare and systemically undermining the patients right to trust his/her physician, despite the area of practice, with making the best medical decision, based on the patients’ needs.

Indeed, in Dr. Schatzlein’s blog, he makes the point that by advertising directly to the consumer, big pharma is, in a sense, undermining the physician who, because they may not prescribe a specific drug, is not, in the patient’s view,  giving the patient the best care.  In fact, the opposite is probably more true, that not prescribing a heavily advertised drug will more than likely, cost the patient less, and is more tailored to their specific situation.  Dr. Schatzlein also mentions a well know heart researcher who is currently hawking the prescription drug Lipitor.  While this researcher did graduate from medical school, he has spent his entire life developing high risk artificial hearts that, while not really successful, garnered him a high degree of fame.  According to Schatzlein, this researcher, after medical school, never sought a license to practice medicine and went straight into research.  So we have this researcher who has never written a prescription, telling consumers this is the best drug for them.  In the Blogmeister’s opinion, it appears that after a life of research (he’s getting up there), this researcher is “selling out” to big pharma to pad his retirement account.

It is exactly this “selling out” to big pharma that Dr. Carlat addresses in an article he wrote for New York Magazine.  The Blogmeister was enthralled with this article which describes the insidious way a good Psychiatrist was turned into a pawn for the drug companies through lavish ego stroking and, of course, cash.  He outlines how his conscience eventually caught up with him and his search to reconcile how he may have misled other physicians and possibly hurt patients, with wanting to be an ethical Physician.

The point of all this is the public needs to trust their Physicians.  They need to know their Physician is prescribing what is best for the patient, despite what  a drug representative just bought them for lunch.  By the same token, patients need to realize, while sometimes the best drug for them is the one with the best marketing campaign, sometimes it is not.  The person to determine that difference is your unbiased Physician.

[Post-script:  As I was fininishing this post, my 10 year old Daughter looked over my shoulder.  She saw the word “Lipitor” and commented, “Oh, I’ve heard of that, it’s on T.V.]

December 8, 2007

Governor Admits Mistakes Made

Governor Mitch Daniels appears to be changing his tune somewhat in the continuing saga of the TaJanay Bailey case.  TaJanay was in foster care until approximately three weeks ago when she was allowed to return to the home of her Mother, Charity Bailey, and her Boyfriend, Lawerence Green.  A Department of Children’s Services minimized concerns and allowed her to return.  She was killed, 11/27/07, allegedly by Green and Bailey. 

The Governor made the following comments at a regularly scheduled press conference on Friday.  The remarks were reported in a story from the Indianapolis Star.

“Gov. Mitch Daniels said someone made the wrong call in the TaJanay Bailey case but that he didn’t know whether anyone should lose their job over the girl’s death.

“The system was very active on behalf of this little girl, and yet someone with the best of intentions — someone who has given a career to the protection of children — finally had to make a call and made the wrong one,” Daniels said Friday at his regularly scheduled meeting with reporters.

Daniels’ press secretary, Jane Jankowski, said the governor wasn’t referring to one particular person.

She also said Daniels had not spoken to any Department of Child Services officials about the case.

“The governor’s role is to build a better-funded, better-operated child services organization. He’s had no direct conversations with DCS about this or any other case,” said Jankowski.

Asked whether anyone should be fired over the case, Daniels responded: “I don’t know the answer to that,” adding that DCS still is working on its internal investigation surrounding TaJanay’s death.

The governor said he still had confidence in DCS Director James W. Payne, a judge he hand-picked for the job.”

 The Fort Wayne Journal Gazette is reporting the press conference somewhat differently.

INDIANAPOLIS – Gov. Mitch Daniels said Friday that state child welfare workers clearly made the wrong call in the case of a 3-year-old girl beaten to death while under state supervision, declaring it a “tragic error in judgment.”

“Human judgment will always enter in, and I guess we will always have to accept that occasionally mistakes like this will be made.”

…”after a lot of discussions someone made a tragic error in judgment and whoever made that error is probably the most heartbroken person around right now,” he said.

Most of these issues have already been addressed by the Blogmeister.  Please see those older posts by searching for “Tajanay Bailey” in the upper right hand corner.

Going After the Owners of Phoenix Apartments

The Indianapolis Star reports in this story that the Indianapolis Housing Authority is going after the company that owns Phoenix Apartments.  This was the apartment complex where three year old TaJanay Bailey was allegedly beaten to death by her mother, Charity Bailey and her boyfriend, Lawrence Green.  Her death followed a return from foster care three weeks earlier and led to the Department of Child Services releasing her records.  Those records showed a supervisor minimized concerns, including those about Phoenix, and returned her to her mother.

The housing authority “wants Connecticut-based RCM Phoenix Partners to return more than $300,000 in federal welfare rent payments for failing to evict unruly tenants and disclose business problems in other cities.”

“Phoenix Apartments, the Northeast side complex that includes the residential block with the most violent crime in the city, was being scrutinized by the agency before TaJanay’s death last week.”

But they still allowed people to live there.  Nice. 

An agency study shows police have received 421 crime reports from residents of the Phoenix Apartments in the past 18 months.

Police say it’s a haven for wanted criminals and stolen cars. Bullets holes have been visible on exterior walls, and residents describe units with mice and cockroaches and frequent plumbing problems.

Among the 421 crime reports at the Phoenix compiled by the Housing Agency are 26 assaults, three with a gun, along with 18 burglaries, 10 drug investigations, 26 vandalism reports and 61 warrant arrests.

In recent years, the Housing Agency has taken administrative actions against about 55 landlords, Myers said. Of those, half have returned the federal welfare rent payments, a quarter have been prosecuted for criminal acts and the remainder dropped out as welfare landlords.

There is a great story here with extensive background and photos.   The Blogmeister can’t understand how the Housing Authority could allow anyone to live there after seeing these photos.

Cleaning out the RSS Feed Barrel

 Most days, the Blogmeister doesn’t get to all the news stories he wants to.  Here are all the stories and posts the Blogmeister either didn’t get to, or were deemed interesting, but not worthy of the Blog, over the past week.

Foster mother of 45 gets help in time of need  
Read This Story: What The Guv’s Tax Plan May Mean For Marion County 
The Fallen Mighty: Allen County GOP Short On Cash After Election  
Kenley Has Devoted Years To Tax Reform, Proposals 
County executive concept develops  :Commissioners back idea; plan may go to legislature.  
Harper’s findings 

Report Ready on Trimming Government
Late filings cost Burton’s PAC $4,450 
Supreme Court will decide Indianapolis case 
Daniels appeals FEMA aid decision 
Suicidal molester sentenced 

Gloomy Hoosiers Opinion 
Senators urging welfare overhaul 
Children dying for lack of child-sized drugs   
Always aroused: A good thing gone awry
Indiana lawmakers consider bill to eliminate township assessors office               
Senate skeptical about appointed assessors        
Republican lawmaker’s support for Daniels’ tax plan is wavering?       
Local Concern: Kenley Cautious In Light Of New Circuit Breaker Data       
Now What? Tully Asks Readers To Chime In With Ways To Fix Phoenix       
Property tax plan to get another look     
Teacher’s post on blog leads to arrest, debate    
Dobson criticizes tax plan:  Commissioner says St. Joseph wouldn’t be able to function under Daniels’ proposal
Working ’10 til 2′ aids at-home professionals 
Lawmaker calls for balance on taxes  
Coming to terms with conflict at the office
Losing virginity early or late tied to health risks 
How depressed is your state?    
Child abuse death isn’t the fault of system 
Brain glitch behind distortion of self-image 
Smaller babies grow up to be sadder adults 
Anorexia risk may start before birth 
Fever can unlock autism’s grip     

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