Safety vs. Safe Use: Why Not Both?

09/15/2008 04:44 PM |

With all the focus on drug safety, what’s gotten lost in the shuffle is the issue of safe use.

According to an April 2007 Harris Poll, more than one-third of Americans surveyed decided not to take a prescribed medicine because of safety concerns about risks and more than a quarter chose not to fill a prescription at all over safety concern.

And, according to Gretchen S. Dieck, Ph.D., senior vice president, Safety and Risk Management for Pfizer, “… surveys of practicing physicians, health policy experts and the general public have revealed a lack of understanding of the fundamental safety science, processes and terminology.  This can contribute to misinformed decisions by patients about treatment options, which can lead to sub-optimal health outcomes.”

To that end, Pfizer Inc announced today the launch of a new interactive online educational resource,

http://www.pfizer.com/responsibility/medicine_safety/medicine_safety_education.jsp

It’s worth a look – and it’s a good conversation starter on the important issue of sharing responsibility when it comes to both the safety and safe use of medicines.

  Read More & Comment...

Insuring Profits

09/15/2008 04:26 PM |

Talk about putting profits before patients!

According to a Medical Society of the State of New survey, the vast majority of physicians practicing in New York say they feel pressure from insurance companies to prescribe certain medical treatments, sometimes at the expense of what is best for patients.

Of the over 1200 physicians surveyed this month, 90% said they changed the way they treat patients based on restrictions from an insurance company, and 92% said incentives and disincentives offered by insurance companies regarding treatment options "may not be in the best interest of patients."

87% of physicians said they sometimes feel pressure to prescribe a treatment based on cost. About 93% of physicians said insurance companies have required them to change prescriptions in the past.

To see how that plays out when you extrapolate private greed to bureaucratic need, click here.

  Read More & Comment...

The Comrade Commissars of Government Health Care

09/15/2008 12:40 PM |

Representative Henry Waxman (D-CA), America’s very own Oversighter-in-Chief, wants to require drug companies to submit reprints of journal articles that discuss off-label use to the FDA before said companies can provide them to physicians.

A modest proposal.

You know what would be even better – what about this – all medical journals have to submit their manuscripts to Mr. Waxman's office before they’re even published in the first place. After all, shouldn’t we address the problem in its most nascent stage?

(Yes, of course, after peer review.)

Better yet, maybe congressionally-appointed health care commissars should sit in on the peer review process of every medical publication? Why not? And, while we're at it, these new comrade commissars should also attend all pre-NDA agency meetings that discuss clinical trial designs.  Needless to say, a statutory voting seat (with veto authority!) on all advisory committies should be de rigueur.

Better still, perhaps PDUFA fees should cover the hiring of FDA political commissars who would have veto power over agency decisions?

These ideas are perfectly consistent with so many other congressional efforts at improving our health care system – just like “academic detailers” – health care commissars of another sort.

Welcome to the Comrade Commissars of Government Heath Care.

And caveat emptor.

  Read More & Comment...

Autism's False Prophets

09/15/2008 04:04 AM |

My review of Paul Offit, MD's new book about the savage war against science being waged by the anti-vaccine movement...

http://www.nypost.com/seven/09142008/postopinion/postopbooks/autisms_false_prophets_128960.htm

Meanwhile the NEJM/media's war against Gardasil's approval for use in women up the age of 26 failed...

Gardasil Approved to Target More Cancers

Sept. 12, 2008 -- The FDA today announced that the vaccine Gardasil may be used to prevent some cancers of the vulva and vagina in girls and women ages 9-26.

Gardasil is already approved to help prevent a leading cause of cervical cancer in women of that same age range.

Gardasil targets four strains of the human papillomavirus (HPV) that cause most cases of cervical cancer. Two of those HPV strains can also cause some vulvar and vaginal cancers.

"There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer," Jesse L. Goodman, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, says in a news release.

"While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV," Goodman says.
http://children.webmd.com/vaccines/news/20080912/gardasil-approved-to-treat-more-cancers

Yeah, well to the media it's all just "hype". 

http://well.blogs.nytimes.com/2008/08/29/blaming-the-media-for-gardasil-hype/

  Read More & Comment...

One Good Pitts Deserves Another

09/12/2008 02:33 PM |

If I do say so myself.

Have a look at our latest newsmaker interview with Representative Joe Pitts (R,PA).
  Read More & Comment...

From Parklawn to Parking on the Lawn

09/12/2008 12:35 PM |

AP reports that Food and Drug Administration has recently hired more than 1,300 professional staffers in a move that “officials hope will help it better protect the public health amid rapid technological and scientific change.”

40% or so of the total positions are paid for via PDUFA fees; ergo the new hires will mainly be evaluating new drugs or medical devices and, in some cases, monitoring safety issues.

That’s great news.  But where are they all going to park? White Oak isn’t even finished yet and already it’s looking like the seating charts will have to be rearranged – particularly since CDER is getting 663 new staffers.

It's a good problem to have.

CFSAN is slotted to get 104 -- a 10% increase (a good start – but not enough). And ORA will grow by 245. Good news.

1,000 of the new hires have already started, with another 158 due to report later this month. An additional 160 have accepted offers. Of those on the job already, more than 850 are professionals, including chemists, biologists, pharmacologists, statisticians, medical officers, microbiologists and field inspectors.

Of the total 1,317 positions, 770 are new jobs and 547 are posts that were left vacant by people leaving the agency for other jobs or due to retirement.

But it’s not all rosy and it’s not as easy as reporting numbers.

The FDA hired nine cancer specialists, but another 20 rejected offers. "They could not make the money they would be making on the outside if they came into public service," said Kimberly Holden, the FDA’s senior manager directing the recruitment initiative. The agency could offer as much as $275,000 a year, she said, but oncologists can make $400,000 annually outside of government service.

All-in-all, it’s a good start. But it’s just the end of the beginning -- and just barely.

  Read More & Comment...

COI Coyness

09/11/2008 02:53 PM |

Here’s the first paragraph from the story in today’s Wall Street Journal on the continuing controversy swirling around academic research and pharmaceutical industry funding:

“WASHINGTON -- Some major universities are reviewing the way they handle funding from drug companies in the wake of criticism from Sen. Chuck Grassley, who is pressing the federal agency that controls government health-research money to get tougher on universities that don't disclose ties to the industry.”

It seems that some academic researchers are being either sloppy or stupid about disclosing research grants they receive from industry.

Giving these folks the benefit of the doubt may be the right thing to do (you know –like “innocent until proven guilty”) but it ain’t gonna happen in today’s shoot-first-and-ask-qustions-later environment – and it could very lead to individual researchers (and their institutions) losing NIH funding.

Here’s what Senator Grassley has to say about the matter:
 
"Starting today, the NIH could send a signal that business as usual is over … The simple threat of losing prestigious and sizable NIH grants would force accurate financial disclosure."

The Senator is right.  But the issue is quickly morphing beyond mere issues of filling out the required forms in at timely manner.

Consider the comments of Jerome Kassirer, the purer-than-pure (despite mega-millions in pharmaceutical advertising revenue), former editor of the New England Journal, "Universities have been treading on dangerous ground with their increasingly complex financial ties to industry.  They are worried that these things could ultimately affect their tax-free status."

Get the picture?

(Note to Jerry – you may be next.)

For more on the COI controversy, please attend our September 22nd conference, "Industry Support for Continuing Education of Health Care Professionals:  An Evidence-Based Evaluation."  There's no cost -- and here's the complete invitation.

  Read More & Comment...

IQWiG Aims at the Stars

09/10/2008 09:58 AM |

“I Aim at the Stars,” was a 1960 B-movie biopic about Wernher von Braun. Many felt that it should have been subtitled, “But sometimes I hit London.”

In keeping with that metaphor, comes news that Germany’s IQWiG (the Institute for Quality and Efficiency in Healthcare) is preparing to test a new cost-benefit methodology towards the end of this month. The test will last for about four months.

To do this it has had to draft a cost-benefit methodology. A first version was put out for public consultation earlier this year and drew many comments (not all laudatory) from stakeholders. Some were critical of the proposed "efficiency frontier analysis" the institute plans to use as the basis of cost-benefit assessments. IQWiG claims that efficiency frontier analysis can be "used in a very flexible manner to compare the cost-benefit relation of any number of therapy alternatives.”

“Flexible” is in the eyes of the beholder.

IQWiG´s new methodology will help determine an “appropriate ceiling” price for drugs that are reimbursed by the statutory health insurers but cannot be included in a reference price group. IQWiG’s assessment will also include a budget impact analysis that can be used in estimating how a decision may affect expenditure in the health care system as a whole.

The cross-channel (and potential cross-Atlantic) implications are especially timely coming on the heels of the Baucus/Conrad bill and while experts are predicting a meltdown of Britain’s NHS.

The answer? According to Sir Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence (NICE), draconian rationing. As he said earlier this week, "Rationing is a necessary evil. We have to do it. There will be losers and winners." That's "universal" health care in its true guise of cost-based "government" health care.

As Tom Lehrer sang, “Once the rocket goes up who cares where it comes down. That’s not my department says Wernher von Braun.”

  Read More & Comment...

The shot not heard 'round the world

09/09/2008 02:11 PM |

Today the NY Times, in a house editorial, tells the truth about vaccines and autism. 

But where are the front page stories?  Where's the outrage? 

Where's the justice?

Here's the complete editorial:

Debunking an Autism Theory

Ten years ago, a clinical research paper triggered widespread and persistent fears that a combined vaccine that prevents measles, mumps and rubella — the so-called MMR vaccine — causes autism in young children. That theory has been soundly refuted by a variety of other research over the years, and now a new study that tried to replicate the original study has provided further evidence that it was a false alarm.

The initial paper, published in The Lancet, the prestigious British medical journal, drew an inferential link between the vaccine, the gastrointestinal problems found in many autistic children and autism. In later papers, researchers theorized that the measles part of the vaccine caused inflammation in the gastrointestinal tract that allowed toxins to enter the body and damage the central nervous system, causing autism.

Now, a team of researchers from Columbia University, Massachusetts General Hospital and the Centers for Disease Control and Prevention has tried and failed to replicate the earlier findings.

These researchers studied a group of 38 children with gastrointestinal problems, of whom 25 were autistic and 13 were not. All had received the vaccine for measles, mumps and rubella. The scientists found no evidence that it had caused harm. Only 5 of the 25 autistic children had been vaccinated before they developed gastrointestinal problems — and subsequently autism. Genetic tests found remnants of the measles virus in only two children, one of whom was autistic, the other not.

The new study adds weight to a growing body of epidemiological studies and reviews that have debunked the notion that childhood vaccines cause autism. The Institute of Medicine of the National Academy of Sciences, the C.D.C. and the World Health Organization have found no evidence of a causal link between vaccines and autism.

Meanwhile, the original paper’s publisher — The Lancet — complained in 2004 that the lead author had concealed a conflict of interest. Ten of his co-authors retracted the paper’s implication that the vaccine might be linked to autism. Three of the authors are now defending themselves before a fitness-to-practice panel in London on charges related to their autism research.

Sadly, even after all of this, many parents of autistic children still blame the vaccine. The big losers in this debate are the children who are not being vaccinated because of parental fears and are at risk of contracting serious — sometimes fatal — diseases.

  Read More & Comment...

Needling while Healthcare Burns

09/09/2008 12:15 PM |

The headline of the AP story says it all, “Congress likely to delay health care overhaul.”

“As Congress returns from summer recess, lawmakers are expected to continue needling pharmaceutical makers and health insurers with investigations, while holding off on major health care reform until next year.”

That’s what this country needs – more needling!

But isn’t health care reform the driving domestic policy issue?  

“Health care has fallen in importance as an issue to voters and that would make one question how aggressive action is going to be next year," said Lehman Brothers analyst Tony Clapsis.

Guess not.

“… analysts are not holding their breath for universal health care coverage, despite some recent rhetoric from the campaign trail.”

"Some" rhetoric? That's generous.

How about less needling, less rhetoric – and more focus on dealing with the problem.  Which aspirant to the White House will have the courage to call for bringing all parties (drug companies, insurance companies, physicians, patients, hospitals, etc.) together to really begin addressing ways to provide access to excellence?

Reform by soundbite is insulting and dangerous.

  Read More & Comment...

Donut Hole Defined

09/08/2008 05:19 PM |

 A new Kaiser Foundation sponsored study uses an IMS data set to look at how many seniors hit the donut hole and what happens when they do.  It turns about about 14 percent go through the point where seniors have to spend up to $3850 of their own money on drugs.  That's about the same as in 2006 according an independent study conducted by IMS itself if you take away seniors who did not spend anyting on prescription.  Adding in seniors that spent nothing you get about 6 percent hitting the donut hole. 

The Kaiser folks wiped out the seniors who spent nothing to plump up the bottom line figure.   Why is one level of spending any less or more important than any other.  Indeed, when doing weighing of distributions you have to add those folks in so that decision was a political one to say the least, not a methodological imperative.  Six percent is still 3 million people.  And it doesn't take away from the fact that both studies found people who hit the hole -- up to one in 10 -- stopped taking their meds for diabetes, depression, Alzheimer's, hypertension and that more than half did not restart after getting catastrophic coverage.  

The biggest problem with the Kaiser study is that it does not compare the behavior of seniors with and without gap coverage indeed the authors admit:

"The IMS database does not provide sufficient information about Part D plans (in particular, it does not distinguish among the multiple plan offerings of a single sponsor) to allow for identification of the small share of enrollees in plans with gap coverage, which prevents us from excluding them from the analysis." 

http://www.forbes.com/forbeslife/health/feeds/hscout/2008/08/21/hscout618675.html

Small share?  Actually over 60 percent are enrolled in plans in gap coverage. 

The interesting policy question is what aren't more seniors choosing plans with gap coverage over the lowball premium plans? 

A further policy question is whether encouraging seniors to switch from an existing medicine in a class -- generic or not -- to another drug is wise.   Gail Shearer of Consumer Union sent a letter to the NY Times arguing that "taking the cholesterol-lowering drug simvastatin (the generic of Zocor) instead of Lipitor saves about $60 to $70 a month. Likewise, many people with acid reflux disease can save $150 to $200 a month by taking nonprescription omeprazole (the generic of former best-selling Prilosec) instead of the much-advertised Nexium. People should raise the issue of drug prices with their doctors to make sure they get prescriptions for medicines they can afford."

http://www.nytimes.com/2008/09/07/opinion/l07Medicare.html?scp=1&sq=gail%20shearer&st=cse

I am glad she urged people to raise the issue with doctors because switching drugs is something people should not do on their own.  Direct to consumer information -- from any source -- should start with patient VALUE in the long term and work from there.   Off the cuff money saving comments can be dangerously expensive otherwise. 

  Read More & Comment...

WSJ Goes Into the Gutter on Sarah Palin

09/08/2008 02:33 PM |

Here's the WSJ's June Kronholz looking into the soul of Sarah Palin and concluding that her newborn Trig is, well, just a cynical political prop:

"Little Trig Palin prompted more than delegate coos when he joined his mother on stage at the Republican convention. He also raised new questions among parents whose children have disabilities.

Was Alaska Gov. Sarah Palin simply including her 5-month-old son, who has Down syndrome, in a big family moment, or was she exploiting him in a tight presidential campaign? Would he help break down social barriers facing children with Down syndrome, or would those children now be drawn into the right-to-life debate?"

Wasn't it the media and the left wing blogosphere who raised all these questions and invaded her family's privacy?  Of course it was and that's where Krumholz went for her "sources."

"Among bloggers' top concerns is a Bush administration measure that would trim Medicaid funding for community services for people with disabilities. Democrats have so far stalled the cuts, which advocates for the disabled said would force the disabled back into institutions.

Blogs also were filled with questions about Gov. Palin's record on services to the disabled during her two years in state office. This spring, Alaska agreed to almost triple its spending on special-needs children, to $73,840 each beginning in 2011. But Gov. Palin didn't help draft the legislation."

She didn't help draft the legislation??  Obviously a sign of neglect!!

..http://online.wsj.com/article/SB122083992345509015.html

  Read More & Comment...

Lies. Damn Lies. And Statistics (about cancer).

09/08/2008 02:17 PM |

A new article in NewsWeek is titled, “We Fought Cancer…And Cancer Won.”

According to the article, “In 2008, cancer will take the lives of about 230,000 more Americans—69 percent more—than it did in 1971.”

That’s true.

The article continues, “Of course, since the population is older and 50 percent larger, that raw number is misleading. A fairer way to examine progress is to look at age-adjusted rates. Those statistics are hardly more encouraging. In 1975, the first year for which the National Cancer Institute has solid age-adjusted data, 199 of every 100,000 Americans died of cancer. That rate, mercifully, topped out at 215 in 1991. In 2005 the mortality rate fell to 184 per 100,000, seemingly a real improvement over 1975."

Also accurate.

Further, “Perhaps the most sobering statistic has nothing to do with cancer, but with the nation's leading killer, cardiovascular disease. Thanks to a decline in smoking, better ways to control hypertension and cholesterol and better acute care, its age-adjusted mortality has fallen 70 percent in the same period when the overall mortality rate from cancer has fallen 7.5 percent.  No wonder cancer "is commonly viewed as, at best, minimally controlled by modern medicine, especially when compared with other major diseases," wrote Harold Varmus, former director of NCI and now president of MemorialSloan-KetteringCancerCenter in New York, in 2006."

Yep.  But what's implicit in what Dr. Varmus says is -- since we're not dying of heart attacks and strokes (thanks largely to pharmaceutical interventions) -- we're living long enough to get cancer.  (Also -- NewsWeek fact-checkers please note --  Varmus wasn't the "former director of NCI," he was the former director of the NIH.)

So, are more people getting cancer?  Yes.  Are more people dying of cancer?  Yes.  Does that mean that we are "losing" the war on cancer?  Not necessarily.

“The meager progress,” according to NewsWeek, “has not been for lack of trying. Since 1971, the federal government, private foundations and companies have spent roughly $200 billion on the quest for cures."

Meager?  Really?

The often ignored reality is that 5-year relative survival rates, for all cancer sites, have increased from 50.1% in 1975 to 65.9% in 2000.

Is cancer close to being “cured?”  No.  Is cancer close to becoming a chronic disease?  It depends.  Is there much work to be done?  Certainly.  Is there need for even more financial investment on the part of both public and private sectors?  Of course.

Is there cause for hope?  Absolutely. And no better reason to embrace and fund the Critical Path program.

  Read More & Comment...

Response to FDA Early "Warning" of Drug Problems is So Predictable

09/08/2008 12:46 PM |

The really, really early warning requirement for new drugs has prompted the predictable response from the usual suspects. The goal of course is to focus post market detective work on which groups of people respond best to which drugs.  But that's not how it's playing out. PhRMA fears people will worry unnecessarily and safety-uber-alles zealots like Diane Zuckerman, president of the National Research Center for Women and Families, worries "It's not going to say how many reports there were. It's not going to say how many died and how many were hospitalized."  

Oh.  And just how high a body count would Diane like?  I have a clue.

Diane, has also said that  anti-depressants don't work and that she knew better than I did because she is an epidemiologist,  When I told her that certain members of my family had responded well to SSRIs she said, "Well, good for you. "   I could feel the love. 

http://ap.google.com/article/ALeqM5jLeef2T5nlybcAAzF3Fe1qqDEaqgD930MUEG0

Like I said, predictable.
  Read More & Comment...

AERS Apparent II

09/05/2008 06:13 PM |

Per the earlier question, "Will the FDA advise a pharmaceutical company in advance if one of their products is to be be included in a quarterly AERS report?" -- the answer is "yes."

According to my source inside the agency, "For all our communications we endeavored to communicate 24-48 hours in advance."

As far as today's inaugural report, sponsors were notified yesterday.

Question:  why not sooner?
  Read More & Comment...

AERS Apparent

09/05/2008 03:28 PM |

The FDA announced today that it will post, quarterly, a report of drugs that are being evaluated for potential safety problems.  The FDA will base this list on adverse events reported through the agency’s Adverse Event Reporting System (AERS). The first report will be posted today.

This reporting mechanism is a requirement of FDAAA.

Ultimately, based on these evaluations, the FDA can require next steps ranging from (1) nothing – if the adverse events are determined not to be drug-related, (2) a risk management plan (REMS), (3) a label change, up to and including (4) a Phase IV clinical trial. It's important to note that all of these options can now, per FDAAA, be mandated by the agency.

This news was presented by Paul Seligman, MD (Associate Director of Safety Policy and Communication, CDER) and Gerald Dal Pan, MD (Director, Office of Surveillance and Epidemiology).  Both commented on the need to keep these warnings in perspective and both spoke to the issue of unintended consequences and that the agency would strive to communicate the information in the manner designed to avoid misinterpretation by patients and overreaction by the media.

(If you disagree that the media overreacts, let's see what happens tomorrow.)

One way to help modulate the unintended consequences (aka, "general hysteria") these things tend to generate is to make sure drug companies have some advance warning of these postings so they can be prepared to communicate their perspectives to patients, physicians and payers.  Will the FDA be advising companies that a given product will be included in the report?  It wasn't discussed during the press briefing.

Inquiring minds want to know (1) if "yes," how far in advance will a company be notified and, (2) if "no," why not?

More as more develops.

  Read More & Comment...

Will Mr. Ross be home for Christmas?

09/05/2008 12:58 PM |

Last night John McCain came out strongly against healthcare reform that would have  “bureaucrats” telling doctors how to practice medicine. 

And he’s right. 

Many people, who disagree with the GOP nominee, echo the empty rhetoric of SiCKO and are calling for healthcare “like in Europe – where it’s free.” 

Well, it ain’t free.  Government-controlled healthcare is funded through (gasp!) taxes.

Consider Canada, while the percentage of taxes used to provide healthcare varies, it is estimated that 22 percent of taxes collected go towards funding of their health system.

Then consider the United Kingdom, so often held up by advocates of "universal" healthcare.

Citizens of the UK pay 11 percent of each pound they make in weekly income between £100 - £670 for the NHS, plus an addition 1 percent of income over £670 a week.

But it’s not only what you pay – it’s what you get (or don’t get) for the money. Consider this story from today’s edition of the British newspaper, The Independent:

“A cancer sufferer whose primary care trust refused to pay for a drug which could extend his life by up to three years has launched an 'end of the road' legal challenge to the decision. If Colin Ross continues to be denied the drug, Revlimid, he will die within a few months, experts say.

Mr. Ross, 55, said his doctors had requested funding for up to four courses of Revlimid at £5,000 a time. "If I don't win and I get no further treatment, I won't be here for Christmas. It's as simple as that," he said.

He was diagnosed with multiple myeloma, a cancer of the blood cells, in May 2004. Doctors at the Royal Marsden Hospital in London deemed Revlimid to be his last chance after side-effects forced him to give up the other life-prolonging drugs he was taking.

Revlimid is readily available to patients in Europe and the US but has yet to be approved by the National Institute of Clinical Excellence. 

In May, West Sussex Primary Care Trust blocked an emergency application for NHS funding for Revlimid for Mr. Ross, saying it was too expensive and his circumstances were not sufficiently exceptional for him to qualify.”

Yes – that’s what the “bureaucrat” said – “his circumstances were not sufficiently exceptional …” 

Yes, by all means, let’s put bureaucrats in control of health care.

Is this the sort of healthcare “reform” we want? 

Is that the sort of “change” we want?

For those who call for “free and universal” healthcare, remember the words of Benjamin Franklin, who said:

"All human situations have their inconveniences.  We feel those of the present but neither see nor feel those of the future; and hence we often make troublesome changes without amendment, and frequently for the worse."

  Read More & Comment...

CME: An Evidence-Based Evaluation

09/04/2008 12:10 PM |

On September 22 in Washington DC, the Center for Medicine in the Public Interest is hosting a half-day conference on pharmaceutical industry support of continuing medical education.  We'll address some key questions such as:

* Is it "true" that industry-sponsored CME helps neither physicians nor patients because it is "biased?"

* Would CME be "better" if industry just gave the same dollars to academic medical centers and hospitals?

* Does barring industry support dampen intellectual freedom and drive talented people out of academic medicine?

We'll be joined by experts such as Tom Stossel, MD (Professor of Medicine, Harvard Medical School), Roger Meyer, MD (Clinical Professor of Psychiatry, Georgetown University), Jack Lewin, MD (President, American College of Cardiology), Gary Puckrein (National Minority Quality Forum), Michael Weber, MD (Professor of Medicine, Downstate Medical Center) and others.

We hope to see you there.  Here's a copy of the complete agenda. 

If you would like to attend (there is no cost), please contact Mario Coluccio at (212) 417-9169 or mario.coluccio@cmpi.org
  Read More & Comment...

The Palin Health Care Record: Results You Can Count On

09/03/2008 01:14 PM |

I will write more about Sarah Palin later, particularly contrasting her decision to have her child Trig while Barack Obama was voting against a bill that made it illegal to deny medical treatment to babies that survived abortions and ghouls like the despicable Howard Brody who root for both aborting and witholding life sustaining care for infants with Down's Syndrome...

The%20healer%27s%20power%20-%20Google%20Book%20Search.webloc

For now it is worth mentioning that when campaigning for governor Palin promised to come up with a plan to provide all Alaskans with the opportunity to purchase affordable healthcare. She did. She established the Alaska Health Care Strategies Planning Council which in turn came up with a proposal to promote transparency of health care costs, deregulation in the formation of health care businesses to promote competition and expanded tax beneftis to support health savings accounts. The Palin plan also redirected state health spending towards electronic medical records, expansion of community health clinics in rural areas and increasing eligibility of the SCHIP program to 200 percent of poverty level. Further, Palin had instructed Alaska's Dept. of Health and Human Services to develop a goal-oriented action plan to improve the quality of care in nursing homes, increase foster care monitoring and quality, reduce child abuse, increase the amount of preventive care covered and paid for by Medicaid, reduce the incidence of SIDS in Alaska which is three times the national average due to a combination of genetic and risk factors unique to the Alaskan-Indian population. Last time I checked, that is called a record of accomplishment and action...

A news account and a copy of the final report of the Planning Council can be found here and here:

Read here

http://www.hss.state.ak.us/hspc/

The HHS goals can be found here: http://www.gov.state.ak.us/omb/09_omb/budget/HSS/  Read More & Comment...

The Truth Hurts

09/03/2008 12:32 PM |

As difficult as it is for parents who have lost children to suicide, the truth is the truth and cannot be ignored.

Consider today's story in the Wall Street Journal:

Elevated Rate Of Teen Suicide Stirs Concern

 
Trend Is Linked to Drop in Use Of Antidepressants After FDA Raised Worries About Risks

By SARAH RUBENSTEIN

A new study may bolster the argument that a drop in the use of antidepressants has led to an increase in teen suicides. Researchers said an analysis that included 2005 data -- the latest available -- shows that a surprising rise in the youth suicide rate in 2004 was largely sustained into the next year. While the rate dropped somewhat in 2005, researchers said, it remained higher than expected. The rise in suicides coincided with Food and Drug Administration advisories about antidepressants that led to an October 2004 decision to require strong "black box" warnings on all antidepressants' labels.

MAKING SENSE OF TEEN SUICIDE

How a trend changed direction.

1990-2003: The suicide rate for people 10 to 24 years old slid more than 28%.

2003-2004: The FDA issued advisories on antidepressants and required 'black box' warnings on labels.

2003-2004: The suicide rate for young people rose 8%.

2004-2005: The teen suicide rate slipped but remained elevated.

Last fall, the U.S. Centers for Disease Control and Prevention said the suicide rate for 10-to-24-year-olds rose 8% from 2003 to 2004 -- after a cumulative drop of more than 28% from 1990 to 2003. The CDC cautioned at the time that it didn't know if the rise was "short-lived" or the "beginning of a trend."

The CDC has monitored the data since then but hasn't come to a conclusion, saying several years of data are needed. But the new analysis by outside researchers suggests the increase "was not a single-year anomaly" and may reflect "an emerging public health crisis," according to a paper being published in Wednesday's Journal of the American Medical Association.

"We're seeing [more than] 600 more suicides in this two-year period than we would have expected, and that is cause for concern," said JeffreyBridge, an epidemiologist at the Research Institute at Nationwide Children's Hospital in Columbus, Ohio, and lead author of the study. A co-author was Joel Greenhouse, a statistician at CarnegieMellon University in Pittsburgh.

The latest analysis could rekindle controversy over the FDA's decision to require the "black box" warnings, which link the drugs to suicidal thoughts and behavior in young people. The warnings, along with the agency's concerns about antidepressants, contributed to a drop in prescriptions of the drugs for children and adolescents. The thorny question for doctors and patients: Are concerns about antidepressants scaring people away from medicines that could help them?

"We've seen this increase as soon as these warnings started, and it is what we were most worried about," said Kelly Posner, a researcher in ColumbiaUniversity's psychiatry department who has helped the FDA collect data on antidepressants and suicide and who says she doesn't have any financial ties to drug companies. "If you look at the whole evidence puzzle, it points in one direction -- antidepressants save lives."

Still, it's unclear whether a drop in antidepressant use is what caused the rise in the suicide rate. The suicide rate pertains to the entire population and doesn't indicate who took antidepressants and who didn't.

Other factors possibly contributing to the rise in the teen suicide rate include alcohol use, access to firearms, the influence of Internet social networks and suicides among U.S. troops, some of whom are older adolescents, Dr. Bridge wrote in the JAMA paper. His study was funded by the U.S. National Institute of Mental Health.

However, responding in part to concerns about avoidance of antidepressants in cases where they're needed, the FDA in 2007 called for an update to the boxed warning, adding that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide. "It is our intent to fully inform prescribers about the risks and benefits of antidepressant prescribing -- not to discourage appropriate prescribing," FDA spokeswoman Sandy Walsh said.

Still, Ms. Walsh said, while the FDA continues to monitor data around the issue, it remains "confident the data support warnings" about suicidal thoughts and behavior in young people, and "it's still good advice to monitor patients starting treatment."

Suicide rates are calculated per 100,000 people. The rate for 10-to-19-year-olds was 4.49 per 100,000 in 2005, down from 4.74 per 100,000 in 2004. However, if the 2003-2004 rise were indeed a fluke, the 2005 figure would have been around 3.8 per 100,000, Dr. Bridge said. In 2003-2004, the increase in the suicide rate among people 10 to 19 was much sharper than the rise in the rate for 20-to-24-year-olds.

Still, the CDC is approaching the data cautiously. Alex Crosby, a medical epidemiologist at the CDC's InjuryCenter, said that in addition to watching the suicide figures, the agency is analyzing data from its National Youth Risk Behavior Survey of high-school students conducted every two years and its National Violent Death Reporting System, which includes details on the circumstances of suicides in 17 states.

The CDC has ramped up efforts aimed at Hispanic adolescents, who report a greater percentage of suicide attempts than other groups, and at Native Americans, who have the highest suicide rate among adolescents and young adults.

Now let's wait and see what the anti-SSRI mafia has to say.  You can bet it'll be vitriolic pharma-bashing with a heaping measure of junk science.

The truth hurts.

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