Drug makers and the White House: House GOP releases docs on health care deals

Note the memo above is cc'd to AstraZeneca's ex CEO David Brennan

House GOP releases documents on health care deals

May 31, 2012, 2:42 p.m. EDT
AP
WASHINGTON (AP) — The White House played political hardball with drug industry honchos to get a 2009 deal that helped keep health care overhaul legislation from bogging down in Congress, according to internal emails released Thursday by House Republicans.

Obtained from the industry by the powerful House Energy and Commerce Committee, the emails and documents shed light on the saga of President Barack Obama's health care overhaul as its fortunes shifted back and forth in Congress.

The basic outlines of the 2009 deal between the drug industry, the White House, and a key Democratic senator were announced at the time, but the emails reveal inside details, such as the wariness participants had for one another, rivalries among insurers, drug makers and hospital groups, and high anxiety on all sides about the progress of the legislation.

The drug industry's $80-billion commitment gave Obama some momentum at a time when health care overhaul appeared to be bogging down on Capitol Hill. Drug makers agreed to help close Medicare's prescription coverage gap, known as the "doughnut hole," and to make other financial contributions.

The companies succeeded in avoiding new requirements to pay rebates to the government for Medicare drugs, their top priority. Ultimately, they also got White House help to beat back a plan that would have allowed Americans to legally import low-cost prescriptions from abroad.

"Taken together, these (emails and documents) help illuminate a previously opaque series of agreements that resulted in a fundamental reshaping of our nation's health care system," said an accompanying report from the committee's Republican staff.

A constitutional challenge to the health care law is now in the hands of the Supreme Court, with a decision expected by the end of June.

The staff report and the release of emails are part of the GOP campaign to fully repeal the legislation. Republicans say the emails show that the White House routinely ignored Obama's promise to openly negotiate health care legislation.

White House spokesman Eric Schultz dismissed the GOP report, calling it a "nakedly political, taxpayer-funded crusade to hurt the president's reelection campaign." Committee Democrats said it merely shows horse trading any president would do to enlist support for major legislation.

Behind-the-scenes negotiations are indeed a normal part of legislation, but things can get testy.

Tension preceded the handshakes between White House officials and pharmaceutical executives.

In the days leading up to the deal, drug makers feared that the White House was going to publicly call for Medicare prescription rebates — dashing industry hopes of quietly squelching that idea.

"Barack Obama is going to announce in his Saturday radio address support for rebating ... unless we come to a deal," Bryant Hall, a top lobbyist for the Pharmaceutical Research and Manufacturers of America, wrote in a Wednesday, June 10 email to a colleague.

"So they are punishing us for being forward leaning. It's laughable and they are burning bridges. They can't get 60 votes for that (to pass the Senate.) It isn't even a real threat."

By that Friday, both sides had stepped back from the brink.

More negotiations followed, and on July 7, a formal meeting sealed the deal. Joining top industry officials were then-White House Chief of Staff Rahm Emanuel, then-health reform coordinator Nancy-Ann DeParle, Senate Finance Committee Chairman Max Baucus, D-Mont., and other officials, the report said. They wanted to look each other in the eye.

A one-page industry summary of the deal, also released, said the White House and Baucus had determined the $80 billion figure.

It said the Obama administration agreed that the final legislation would not include any Medicare prescription drug price controls, not even for low-income beneficiaries who also participate in Medicaid. The industry committed to run positive advertising in favor of revamping the health care system.

As word of the deal got out, some leading Democrats in the House complained that they were cut out and asserted they wouldn't be bound by its terms.

They didn't get very far. The industry's deal with the White House stuck."

___

Online:

House Energy and Commerce Committee - HERE

the pdf link.

Allen Frances MD: "DSM-5 Costs $25 Million, Putting APA in a Financial Hole"

Via HuffPo DSM-5 Costs $25 Million, Putting APA in a Financial Hole:

"The American Psychiatric Association just reported a surprisingly large yearly deficit of $350,000. This was caused by reduced publishing profits, poor attendance at its annual meeting, rapidly declining membership, and wasteful spending on DSM-5. APA reserves are now below "the recommended amount for a non-profit (reserves equal to a year's operating expenses)."

APA has already spent an astounding $25 million on DSM-5. I can't imagine where all that money went. As I recall it, DSM-IV cost about $5 million, and more than half of this came from outside research grants. Even if the DSM-5 product were made of gold instead of lead, $25 million would be wildly out of proportion. The rampant disorganization of DSM-5 must have caused colossal waste. One obvious example is the $3 million spent on the useless DSM-5 field trial, with its irrelevant question, poorly conceived design, and embarrassing results.

Because APA is left holding these huge IOUs, it will be doubly desperate to begin recouping on its misguided investment. The bad financial report will ratchet up the pressure to publish DSM-5 in its current, sorry state as scheduled next May, despite the fact that it has badly flunked its own field test and now still requires extensive editing and retesting before being anywhere near fit for use.

The only way to restore credibility to DSM 5 would be postpone its publication until it can be done right. This means reinstating the quality control step that was cancelled when DSM-5 kept failing to meet its own deadlines. Prematurely publishing a poor-quality DSM-5 would be nothing less than a cynical business ploy, violating what should be APA's sacred duty to protect the public trust."-Allen Frances, MD

Read the rest HERE.

Dr Charles Nemeroff is once again the target of Senator Grassley's investigation over NIH grant

Senator Grassley goes after Dr Charles Nemeroff for the recent NIH grant

http://psychiatry.med.miami.edu/About-Department/Faculty120/Charles-Nemeroff.aspx

http://www.modernhealthcare.com/article/20120529/NEWS/305299975/grassley-questions-grant-to-sanctioned-researcher#

http://freepdfhosting.com/ee8f43562b.pdf

hat tip via @Pharmalot

http://www.pharmalot.com/2012/05/grassley-probes-nih-over-new-nemeroff-grant/

Further reading
Senator Grassley Questions New Federal Grant To Research Physician

"Senator Chuck Grassley is asking the National Institutes of Health to explain why it has awarded a $400,000 medical research grant to a physician who it banned from NIH funding in recent years for failing to disclose a $1.2 million financial relationship with a major pharmaceutical company while leading a $9 million federal study involving that drug company’s blockbuster depression drug Paxil.

Last year,the Obama administration scrapped a proposed conflict of interest rule that would have required universities to disclose financial relationships between medical researchers and the pharmaceutical industry to be posted on publicly available websites.

Grassley has pursued an extensive campaign for disclosure of payments made by drug and medical device makers to physicians since 2007, when he began to expose dramatic disparities between what was reported and what was, in fact, received.

One of those cases involved the doctor receiving the grant in question today, Dr. Charles B. Nemeroff. In 2008, documents revealed that Nemeroff, who was then chair of Emory University’s psychiatry department, failed to disclose that he received $1.2 million in consulting fees from GlaxoSmithKline, the maker of Paxil, while leading federal research on the treatment of depression.

Nemeroff left Emory University and was then hired by Miami University. The Director of the National Institute of Mental Health within NIH weighed in on Nemeroff taking this new position. While the NIH said that Nemeroff could not receive federal medical research dollars for two years, the ban has expired and, regardless, it did not apply to him in a position at a new university.

In addition, Nemeroff remains under investigation by the Inspector General for the Department of Health and Human Services, which is working with the Department of Justice on the case. In his letter today, Grassley asked the NIH if this was considered. "There has been no final resolution by DOJ or public finding by HHS OIG related to the investigation of Dr. Nemeroff. Yet, NIH awarded him another grant,” he said.

Grassley said the decision by NIH “risks sending the wrong message to physicians seeking or performing federally funded research.”"

"Does anyone deserve to have their brain and gene functioning altered, perhaps permanently by psychiatric medications?" asks Michael Cornwall, Ph.D.

VIA Mad in America HERE

Does Anyone Want a Genetically Modified Brain? – Anti-Psychotic Medications May Have Been Causing It To Happen All Along

Posted on May 28, 2012 by Michael Cornwall, Ph.D.

Move over outdated chemical imbalance theory, now it is claimed that genetic misregulation underlies psychiatric disease, and that psychiatric drugs themselves can fix the genetic misregulation problem. ”Anti-psychotics and mood stabilizing agents are capable of promoting epigenetic modifications associated with an active transcriptional state at disease-relevant loci, suggesting new molecular mechanisms of anti-psychotic efficacy” says the just released report by the Toronto-based Krembil Epigenetics Laboratory.

Read the entire article here where Cornwall asks "Does anyone deserve to have their brain and gene functioning altered, perhaps permanently by psychiatric medications?"

My answer? NO. How many people (adults and children!) are prescribed these drugs without knowing the fine print, of just what they are taking? the lack of informed consent along with the lack of efficacy and safety use for long term studies are enough to question this medical model of drug based treatment for psychiatric care in America.

Senator Grassley et al file amendment to combat widespread use of antipsychotics in nursing homes

Via Senator Charles Grassley Kohl, Grassley and Blumenthal Seek to Cut Misuse of Antipsychotics

WASHINGTON – U.S. Senators Herb Kohl, D-Wis., Chuck Grassley, R-Iowa, and Richard Blumenthal, D-Conn., today filed an amendment seeking to combat the costly, widespread and inappropriate use of antipsychotics in nursing homes.

“The overuse of antipsychotics is a common and well-recognized problem that puts frail elders at risk and costs taxpayers hundreds of millions of dollars each year,” Kohl said. “We need a new policy that helps to ensure that these drugs are being appropriately used to treat people with mental illnesses, not used to curb behavioral symptoms of Alzheimer’s or other dementias.”

“This amendment responds to alarming reports about the use of antipsychotic drugs with nursing home residents,” Grassley said. “It’s intended to empower these residents and their loved ones in the decisions about the drugs prescribed for them.”

“This measure is responsive to mounting evidence that antipsychotics are being misused and overused in the nursing homes we trust to care for our loved ones,” Blumenthal said. “The amendment will do what is necessary to curb this deeply concerning practice, putting the power to make key health care decisions back into the appropriate hands and eliminating unnecessary costs to taxpayers.”

The amendment to S. 3187, the Food and Drug Administration Safety and Innovation Act would require the Health and Human Services Secretary to issue standardized protocols for obtaining informed consent, or authorization from patients or their designated health care agents or legal representatives, acknowledging possible risks and side effects associated with the antipsychotic, as well as alternative treatment options, before administering the drug for off-label use.

While the Food and Drug Administration (FDA) has approved antipsychotic drugs to treat an array of psychiatric conditions, numerous studies conducted during the last decade have concluded that these medications can be harmful when used by frail elders with dementia who do not have a diagnosis of serious mental illness. In fact, the FDA issued two “black box” warnings citing increased risk of death when these drugs are used to treat elderly patients with dementia.
Last year, the Health and Human Services Office of the Inspector General (HHS OIG) issued a report showing that over a six-month period, 305,000, or 14 percent, of the nation’s 2.1 million elderly nursing home residents had at least one Medicare or Medicaid claim for atypical antipsychotics.

The HHS OIG also found that 83 percent of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions and that 88 percent were associated with a condition specified in the FDA box warning. Further, it showed that more than half of the 1.4 million claims for atypical antipsychotic drugs, totaling $116.5 million, failed to comply with Medicare reimbursement criteria.

The amendment also calls for a new prescriber education program to promote high-quality, evidence-based treatments, including non-pharmacological interventions. The prescriber education programs would be funded through settlements, penalties and damages recovered in cases related to off-label marketing of prescription drugs.

" If you engage in corrupt behavior, there will be no long term consequences.” Charles Nemeroff receives NIH grant money--what?

Charles Nemeroff news

" If you engage in corrupt behavior, there will be no long term consequences.” says Paul Thacker, ex- Charles Grassley and POGO investigator in the article at Pharmalot Nemeroff Gets His First NIH Grant In Three Years:

" “This shows that the NIH is simply incapable of handling conflict of interest problems in an adult, professional manner,” Paul Thacker, a former invesigator for US Senator Chuck Grassley, who ran the Senate probe, tells us. “Nemeroff is back on the federal dole because he’s made friends with NIH hierarchy. Not because his research is critical to public health.The NIH just sent a message to all federally funded researchers. If you engage in corrupt behavior, there will be no long term consequences.”

A parent's worst nightmare--tragic death of son by suicide after taking antidepressant Lexapro, Cipralex, Escitalopram

About 7 minutes into this video, Nancy McCartney is interviewed about the death of her son, Brennan from suicide after being prescribed antidepressant Cipralex (Escitalopram)(Lexapro in U.S.) in Canada. Nancy tells me on twitter, that Ontario coroner has refused to do any toxicology. The interview also features Dr. David Healy.

It's here: under the tongue "Ambien", mint flavored--take in bed! being marketed by the maker of OxyContin

This is a great article (linked below) by MARIANNE SKOLEK, COLUMNIST FOR AMERICAN NEWS REPORT. Her bio in the article states she is a parent a daughter lost to OxyContin in 2002, and she writes from the perspective of an activist fueled by anguish and outrage--

Intermezzo is a sub-lingual (under the tongue) version of the popular sleeping aid Ambien (has the key ingredient zolpidem, and, according to the article, is being marketed by Purdue Pharma, the same drug company in the news for the pain killer OxyContin (see William Heisel's story--Bioethics Center with Money Ties to Big Pharma Has Habit of Downplaying Painkiller Risks.

The pill is mint flavored and designed to market to people who wake up in the middle of the night and can't go back to sleep. It's designed to be taken while lying in bed. The drug (Intermezzo) was approved by the FDA after just a few trials on a few (300+)people.

Take a look at Marianne Skolek's article--Intermezzo: A Nightmare Drug for Insomniacs?.

Mother, reporter, activist: Marianne Skolek's testimony to the U.S. Senate 2007--"My name is Marianne Skolek.

.."I had a beautiful 29 year old daughter named Jill. She had the misfortune of being prescribed OxyContin in January 2002 and was killed on April 29, 2002. Jill left behind her son Brian who was 6 years old at the time of his mom's death. Brian is with me in the Senate today.

Why did a $9 billion privately held pharmaceutical corporation take the life of my precious daughter? My work against Purdue Pharma for the past 5 years initially focused on J. David Haddox, dentist turned psychiatrist and Senior Medical Director of Purdue Pharma. I also focused on Robin Hogen, former Public Relations spokesman for Purdue Pharma." (read the rest at the link).

Risk of cancer increases by 19% from use of benzodiazepines

STUDY: Benzodiazepine Use Possibly Increases Cancer Risk: A Population-Based Retrospective Cohort Study in Taiwan

"Objective: To evaluate the possible association between benzodiazepine use and subsequent cancer risk in Taiwan.

Method: In this population-based retrospective cohort study, we used data from 1996 to 2000 from the Taiwanese National Health Insurance system to investigate the possible association between benzodiazepine use and cancer risk. The exposure cohort (mean age = 47.9 years, standard deviation [SD] = 17.3 years) consisted of 59,647 patients with benzodiazepine use. Each patient from the exposure cohort was randomly frequency-matched by age and sex to a person from the cohort with no benzodiazepine exposure (the comparison group; mean age = 46.4 years, SD = 17.8 years). Each study subject was followed until a diagnosis of cancer was made (according to ICD-9-CM) or until the time the subject was censored for loss to follow-up, death, or termination of insurance—or to the end of 2009. A Cox proportional hazard regression analysis was conducted to estimate the effects of benzodiazepine use on cancer risk.

Results: In the group with benzodiazepine use, the overall risk of developing cancer was 19% higher than in the group without benzodiazepine exposure, and the difference between the groups was statistically significant (hazard ratio [HR] = 1.19; 99.6% CI, 1.08–1.32). With regard to individual types of cancer, the risk of developing liver cancer (HR = 1.45; 99.6% CI, 1.10–1.90), prostate cancer (HR = 1.72; 99.6% CI, 1.10–2.70), and bladder and kidney cancer (HR = 1.76; 99.6% CI, 1.16–2.67) was significantly higher for the benzodiazepine cohort.

Conclusions: This population-based study has shed light on a possible relationship between benzodiazepine use and increased cancer risk. Further large, thorough investigations are needed to confirm these findings."

A Vision for Transformation: Mental Health Freedom and Recovery Act by Duane Sherry

VIA the Mad in America blog, A Vision for Transformation: Mental Health Freedom and Recovery Act Duane Sherry voices an Op-Ed which includes a link to his blog Discover and Recover where he has written "Mental Health Freedom and Recovery Act":

Mental Health Freedom and Recovery Act--includes informed consent, recovery model,psychiatric drug withdrawal centers and more go take a look at both, this is the vision that people need to have to shift the current medical treatment model for psychiatry which is based solely on psychiatric medications for treatment and long-term care for psychiatric issues.

Allen Frances:"Psychiatric diagnosis is simply too important to be left exclusively in the hands of psychiatrists"

Allen Frances on the DSM 5

via OP-ED CONTRIBUTOR-Diagnosing the D.S.M.-By ALLEN FRANCES

"All mental-health disciplines need representation — not just psychiatrists but also psychologists, counselors, social workers and nurses. The broader consequences of changes should be vetted by epidemiologists, health economists and public-policy and forensic experts. Primary care doctors prescribe the majority of psychotropic medication, often carelessly, and need to contribute to the diagnostic system if they are to use it correctly. Consumers should play an important role in the review process, and field testing should occur in real life settings, not just academic centers.

Psychiatric diagnosis is simply too important to be left exclusively in the hands of psychiatrists. They will always be an essential part of the mix but should no longer be permitted to call all the shots.

Allen Frances, a former chairman of the psychiatry department at Duke University School of Medicine, led the task force that produced D.S.M.-4." Allen Frances, NYT

Cause of Death: Unknown Website Announcement at Occupy the APA, May 5, 2012

Andrew Grant


"Andrew Grant, the Berlin, Germany-based producer of a documentary for Norwegian filmmaker Anniken Hoel titled, CAUSE OF DEATH: UNKNOWN, announces a soon-to-be launched website where people can report on deaths and harm caused by psychiatric drugs at Occupy the American Psychiatric Association, in Philadelphia, Pennsylvania, USA, May 5, 2012."

APA 2012 a social media extravaganza!

The twitter hashtag #APAAM12 used for the American Psychiatric Association's annual meeting 2012 in Philadelphia was a fast-moving bonanza of information coming from psychiatrists, social media hounds, and APA protesters and more. At the beginning of the meeting there were tweets about the protesters:

There was chatter by psychiatrists, such as Dr. Bob Hsiung, a long time Internet user and creator of "Psycho-Babble" site

There were journalists writing about the DSM-5 who were in attendance at the APA meeting and that writer walked out of a symposium:

"“Totally deceptive,” I said. I swung my backpack over one shoulder and walked out of the room." wrote Ferris Jabr from Scientific American.

There was a workshop given by psychiatrists on the public image of psychiatry, where Dr. Bob used real-time tweets as part of his presentation in his slide presentation:

"We Have Seen Psychiatry’s Public Image and It Is Ours http://www.dr-bob.org/talks/apa12.ppt "

There were cartoon commentaries

And there was something unexpected, and unique to the conversation between Psychiatrist's and critics that happened:Dr.Bob shows the love to pharma-psychiatry critic @writewithStan where upon reading that, I exclaimed, "Now I've seen it all!"

For a great round-up and wrap up by the wise and retired psychiatrist 1 Boring Old Man, go HERE where he takes apart the DSM-5 topic piece by piece.The chimp image above depicting the DSM-5 task force and the cartoon was created by writewithstan who never fails to inject humor into these discussions!

Last but not least, this was also a hashtag on twitter where I found via Dr.Steve Daviss, the author of an interesting article on Zoloft and cell eating (autophagy) by yeast. This was slightly confusing as to how it (the info from the study)applies to humans, so Dr.Daviss asked the author to clarify which he did, and you can read the author's answer here.

BY being part of the #APAAM12 hashtag and reading it for days, I was able to keep a pulse on the happenings, where there were lots of "Dollars for Docs" KOLs tweeted about when they were giving their KOL talks to attendees, there were tweets from pharma cos, tweets from protesters of the APA, and lots of social media contacts to be made and observed.

I feel the use of social media this way is a positive one where all voices can be heard, and if "psychiatry" was truly listening, they would use this tool to their advantage, to keep a pulse on what the outside world is saying about their profession. This is what Dr. Bob seemed to do.

If you watch or listen to anything today, let it be this

If you listen and watch anything today let it be this:

Jim Gottstein news interview "Mind over Meds" Jim Gottstein, attorney who brought Zyprexa docs to public Gottstein, on Alaska TV news, discussing his recovery from a psychotic break, he is inspirational in so many ways.

Internal ZYprexa documents prove Lilly marketed the antipsychotic Zyprexa knowing it could cause diabetes and weight gain.

Father and son: medication, court-ordered

Film, "That's Crazy" link here:from the site:

"Eric, a genetics major, and his father, a doctor living in Madison, Wisconsin never imagined they would challenge the mental health system. But when Eric, diagnosed as schizophrenic, decided to refuse his medications because they made him feel worse, the county issued a set of court orders that allowed police to pick him up and take him to a local hospital to be force medicated. Eric’s decision to refuse involuntary treatment with the help of his family triggers a series of personal, medical and legal battles that are captured by everybody involved as the events take place in real time. Eric's goal - to try a talking based treatment that has the highest success rate for psychosis in the world. Leading mental health activists and allies such as David Oaks and Robert Whitaker explore the science and the ideas behind the movement that believes people like Eric have a right to a voice and a choice in their treatment. Stylized verite reveals the story - animation by Em Cooper illustrates the inner experience."

APA 2012 Dr. Daniel Carlat and the Shrink Rap bloggers: "gaining control of our specialty's public image"

What's wrong with the medical model of mental health care in America? Lists like these of doctor's pharmaceutical financial disclosures in the APA meeting in Philly 2012

Open publication - Free publishing - More apa

Flip through the book--Shrink Rap bloggers are giving a panel talk with Dr. Daniel Carlat and Dr Steve Balt titled, " Psychiatrists and the new media--gaining control of our specialty's public image" (page 149)and other interesting psychiatry tidbits.


I wonder how they will decide to gain control of psychiatry's public image?