Nissen to JAMA to Harris

09/12/2007 10:26 AM |

It's not a new double play combo, it's the tired old triangle of terror trying to undo the measured approach the FDA took on Avandia. Flawed, cherry picked data that was held backed after the Adcomm (one can see the eyes rolling if GSK presented similar data to support Avandia's safety...oh wait, it did, it's called RECORD and it's a lot better than a meta-analysis of clinical trials that did not have safety as an endpoint).

If you want your peer review to be your cronies at the NY Times and not scientists, that's what you do.

http://www.nytimes.com/2007/09/12/health/12drug.html?_r=2&adxnnl=1&oref=slogin&adxnnlx=1189600152-vjb/dQOVeGSyHepZfiwa8w&oref=slogin  Read More & Comment...

September 11th and Risk

09/11/2007 05:09 PM |

From today's edition of the Wall Street Journal ...

Risk-Based System Urged for Import Safety
By JANE ZHANG
September 11, 2007

WASHINGTON -- A White House panel studying ways to improve import safety said the U.S. should shift to a preventive system focused on risky products, conceding that the U.S. can never inspect enough foreign goods to protect consumers from every potentially harmful item.

Under such a system, the government would collect data from private and public sources, identify safety hazards along the entire "life cycle" of the imported products and manage the risk earlier in the import process. A database for such use is already being developed and officials say its implementation could be pushed to 2009 from 2011.

"It's a change from an intervention-focused strategy to a risk-based approach focused on prevention with verification," said Health and Human Services Secretary Mike Leavitt, who heads the panel of senior officials from 12 federal agencies. "Instead of a point-in-time assessment at the border, we're recommending a focus on the full import life cycle, building safety into the products that we purchase every step of the way."

The risk-based concept isn't new. Major elements of the recommendation mirror a 2002 Food and Drug Administration proposal aimed at improving import safety, but was shelved because of, among other reasons, a lack of funding. Earlier this year, FDA officials dusted off the plan after a spate of food scares put them under fire on Capitol Hill.

The panel's recommendation, if adopted, would apply to all agencies that regulate imports, such as the Consumer Product Safety Commission. Mr. Leavitt declined to say how much the system would cost, or what specific actions are needed. The panel is scheduled to release action plans in November.

The Bush administration has been grappling with import-safety issues in the wake of a string of recalls and problem products, including toys, tires, seafood and tainted pet-food ingredients, almost all from China. (See related article.)

The turn of events pleased some food-safety experts. "It's a good thing they've gone back to the FDA's early thinking," said William Hubbard, a former FDA associate commissioner. "The question is whether sufficient funding can make it happen."

But Benjamin England, a co-author of the 2002 FDA plan who now runs a consulting firm, FDAImports.com, said Mr. Leavitt's recommendation falls short of addressing solutions to the current import mess.

"In an effort to elevate from an intra-agency risk-based program to an inter-agency risk-based program, a lot was lost in translation," he said. For example, the report didn't define risk, didn't place more responsibility onto foreign manufacturers and the proposed data system is intended more for collecting trade data than assessing risks with products.

U.S. officials are also holding private discussions with Chinese regulators, both in the U.S. and in China, to enhance the safety of products such as food and drugs.

In Beijing, China's top quality-inspection official challenged U.S. regulators to play a more active role in screening Chinese exports for tainted goods, proposing that the FDA ban products from companies that haven't passed muster with Beijing in order to weed out the most flagrant violators. An FDA spokesman said the agency looked forward to working with the Chinese, but declined to elaborate.

Yesterday, U.S. and Chinese regulators agreed on a plan to eliminate lead in toys from Chinese companies and to enhance scrutiny of the toy-making process, people familiar with the talks said. Details will be announced today at the Second Biennial Sino-U.S. Consumer Product Safety Summit here.  Read More & Comment...

Ending the Embargo on the Truth

09/10/2007 10:19 AM |

We are sharnig, ahead of an embargo, an editorial and a release on two separate articles being issued by JAMA on Sept 11. One co-authored written by Curt Furberg and his colleagues at Wake Forest is entitled " Long-term Risk of Cardiovascular Events with Rosiglitazone" (Avandia) and another by Steve Nissen and colleauges on Pioglitazone and Risk of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus A Meta-analysis of Randomized Trials (Actos) The one by Nissen claims that Actos reduces risk of heart problems but has no impact on overall death from heart disease. This claim is made from a dataset that is observational, does not control for serverity of heart problems and does not have MI or heart safety as a primary endpoint. The one by Furberg -- a meta-analysis of only 4 clinical trials (a meta-analysis that must set some sort of record for being the smallest ever accepted for publication) claims that Avandia long term has a high risk of MI among long term users yet has no long term impact on total incidence of death from heart problems. That's sort of like saying that driving a certain kind of car leads to more car crashes by no increase in accidents or deaths.

We feel that the increased need for transparency, particularly in the wake of disturbing revelations that the release of safety studies directly to the media or to Congress have lead in the case of SSRIs, diabetes drugs and even pain killers to an over reaction of the public with adverse public health consequences justifies ignores this embargo. Indeed, the embargo is being used to subvert and undermine the ongoing post market review process of the FDA with respect to TZDs.

Both articles ignore and fail to cite the FDA data claiming no increased risk of heart problems apart from heart failure from Avandia and the problems of using observational data that did not have MI as a primary endpoint. Both articles fail to include more recent meta-analysis and re-analysis showing a lower risk of heart problems from Avandia from the Archives of Internal Medicine. (Diamond GA, Bax L, Kaul S. Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death. Ann Intern Med. 2007 Aug 6; [Epub ahead of print] ) Who's doing the peer review at JAMA these days?

And of course the articles are followed by an editioral calling for Avandia to be yanked from the market. That's a far cry from even a recommendation for a black box for MI which even Nissen et al conjecture might be associated with high cholesterol and treated with statins in this article.

The authors could have very well presented these findings at the Adcomm. Knowing the timing of the publication process as we do, it is clear that JAMA, NIssen and Furberg had the information in this article in advance of the FDA Adcomm hearing. Indeed, their reference to the proceedings, their willful refusal to acknowledge alternative findings from the hearings or from other peer-reviewed journals suggest that the publication of these articles are yet another attempt, much like the release of the original NEJM article to usurp the FDA's authority, engage in fearmongering and undo a careful consensus on drug safety evaluation.

Honoring an embargo that undermines the authority of duly constituted regulatory agency is not honorable. The first time it led to chaos and a near public health crisis. We release these articles now with our comments in the hope that we can contain whatever damage Nissen, Furberg and JAMA intended with the anticipated publicity. These articles should have been part of the public record and public debate. They were deliberately withheld to allow them to engage in drug safety vigilantism. That is an abuse of power that honoring the embargo only perpetuates at the expense of the FDA's authority.

Glycemic Control Medication Pioglitazone Appears to Have Overall Favorable Effect Regarding Risk of Cardiovascular Events

CHICAGO – A meta-analysis of previous research suggests that use of pioglitazone, a glycemic control medication for patients with type 2 diabetes, significantly reduces the risk of heart attack, stroke and death, but increases the risk for serious heart failure, according to an article in the September 12 issue of JAMA.

A. Michael Lincoff, M.D., and colleagues at the Cleveland Clinic, conducted a meta-analysis of research to evaluate the effect of pioglitazone on the incidence of ischemic cardiovascular complications for patients with type 2 diabetes. Previous evidence had been insufficient to evaluate this effect. This analysis included 19 randomized trials and 16,390 patients. Duration of pioglitazone use ranged from 4 months to 3.5 years.

The researchers found that heart attack, stroke or death occurred in 375 (4.4 percent) of 8,554 patients receiving pioglitazone and 450 (5.7 percent) of 7,836 patients treated with control therapy, an 18 percent relative reduction. These outcomes were all reduced by a similar magnitude with pioglitazone treatment. Serious heart failure was reported in 200 (2.3 percent) of pioglitazone-treated patients and 139 (1.8 percent) of control patients.

“These findings suggest that the net clinical cardiovascular benefit with pioglitazone therapy is favorable, with an important reduction in irreversible ischemic events that is not attenuated by the risk of more frequent heart failure complications,” the authors write.

(JAMA. 2007;298(10):1180-1188.)

Long-Term Use of Glycemic Control Medication Rosiglitazone Associated With Increased Risk of Heart Attack and Heart Failure

Patients with type 2 diabetes or impaired glucose tolerance who take the medication rosiglitazone appear to be at increased risk for a heart attack or heart failure, according to a meta-analysis article in this issue of JAMA.

Sonal Singh, M.D., of the Wake Forest University School of Medicine, Winston-Salem, N.C., and colleagues reviewed research to examine the risk of heart attack, heart failure and cardiovascular death with long-term rosiglitazone use. There have been recent reports of serious adverse events with rosiglitazone use, but information available to clinicians on the magnitude and public health impact of these events has been limited.

The researchers compiled data from four randomized trials that included 14,291 patients (n = 6,421 receiving rosiglitazone; n = 7,870 receiving control therapy). Follow-up for these studies was 1-4 years.

The pooled data from the trials indicated that rosiglitazone, compared with controls, significantly increased the risk of heart attack by 42 percent (94 of 6,421 patients who received rosiglitazone vs. 83 of 7,870 patients who received control therapy) and doubled the risk of heart failure (102 of 6,421 patients vs. 62 of 7,870 patients). Use of rosiglitazone was not associated with a significant increase in risk of cardiovascular death.

“Our findings have potential regulatory and clinical implications. These data suggest a reversal of the benefit-to-harm balance for rosiglitazone present at the time of approval. Thus, currently there appear to be much safer treatment alternatives. Regulatory agencies ought to reevaluate whether rosiglitazone should be allowed to remain on the market. Health plans and physicians should not wait for regulatory actions. They should avoid using rosiglitazone in patients with diabetes who are at risk of cardiovascular events, especially since safer treatment alternatives are available,” the authors conclude.

(JAMA. 2007;298(10):1189-1195.)

Editorial: Cardiovascular Risk and the Thiazolidinediones – Déjà Vu All Over Again?

In an accompanying editorial, Daniel H. Solomon, M.D., M.P.H., and Wolfgang C. Winkelmayer, M.D., Sc.D., of Brigham and Women’s Hospital, Harvard Medical School, Boston, comment on the findings in this week’s JAMA regarding glycemic control medications and drug safety.

“The previous episode with the selective COX-2 inhibitors and the current one with the thiazolidinediones are instructive for designing a better drug safety system. First, early safety concerns must prompt strong and clear regulatory action. … Second, postmarketing adverse events not frequently observed in premarketing studies should be expected when there is incomplete understanding of the mechanism of action of a drug.”

“Third, after several drugs are available for a given indication, new drug approval should be based on improvement in clinical outcomes, not surrogate measures. … Fourth, the decisions for initial approval of a drug and subsequent continued marketing should by symmetric. … Finally, and perhaps most difficult, safety and efficacy must be explicitly balanced when drugs are being considered for approval or for continued marketing.”

(JAMA. 2007;298(10):1216-1218.  Read More & Comment...

AHRQ Diocese

09/10/2007 08:13 AM |

Comparative effectiveness? Well since you mentioned it ...

CBO’s Estimate of the Budgetary Impact of Section 904

(Sec. 904. Comparative effectiveness research. Establishes within the Agency of Healthcare Research and Quality a Center for Comparative Effectiveness Research to conduct research on the outcomes, effectiveness, and appropriateness of health care services.Also establishes an independent Comparative Effectiveness Research Commission to set priorities and ensure credibility for the Center’s work. It also establishes a Comparative Effectiveness Research Trust Fund, initially funded through the Medicare trust fund, to support the work of the Center and the Commission.)

* CBO estimates that Section 904 of the CHAMP act (H.R. 3162) would increase Federal spending (Medicare, Medicaid, and FEHBP) by $600 million between 2008 to 2012, and $2.4 billion from 2008-2017.

* While the agency estimates that the bill could reduce public and private health spending by up to $6 billion, direct Federal spending would only be reduced by $100 million over the 2008-2012 period and $1.3 billion between 2008 and 2017. (Those amounts would constitute a very small fraction of overall federal outlays for those programs.)

* Thus, enacting section 904 would increase federal direct spending by $0.5 billion over five years and $1.1 billion over 10 years.

* CBO assumes that the provision would result in better information about which health care services and procedures are ineffective and some changes in coverage rules that can be implemented under current law.

Well that's certainly reassuring.  Read More & Comment...

Medical Quackery

09/07/2007 04:48 PM |

In my op-ed in today's Washington Times I compare Jerry Avorn's disdain of a drug for blacks that reduces death from stroke by 43 percent with his love of a one-size fits all prescribing pattern that raises it by 40 percent.

Why does he love one and hate the other?

Because one favors new drugs and the other favors old drugs.

http://washingtontimes.com/article/20070907/EDITORIAL/109070006/1013/EDITORIAL  Read More & Comment...

Ads Infinitum

09/07/2007 08:12 AM |

Two cheers for the American Cancer Society's efforts to focus attention and its advertising dollars on the nation's health access problem -- specifically the uninsured. We're holding the third cheer in reserve because of our concern that policymakers will interpret these commercials as an endorsement of a single-payer, "universal" healthcare system. We're also not 100% convinced that this is the best way for the ACS to spend its money -- but that's their business.

The ACS says that is has "no position" on what kind of health system should be in place in the U.S. Here's a suggestion -- how about one that delivers the highest rate of cancer survival in the world.

According to a recent study in the respected Lancet Oncology -- the most comprehensive ever conducted -- America's cancer-survival rate is the highest in the world among both men and women. By contrast, Britain -- despite its reputation as a utopia of "free" healthcare -- has some of the lowest survival rates in the western world.

Improved access is an worthy goal -- but a single-payer system is not the answer -- especially for cancer patients.

And the American Cancer Society should be brave enough to say so.   Read More & Comment...

What's Really Depressing....

09/06/2007 01:03 PM |

FiercePharma call the increase in suicides in the wake of SSRI fearmongering "unforseen." I love FiercePharma's reporting but I think they are wrong in this instance. Unforseen? About as unforseen as insulin going out of control when you stop using Avandia.

http://www.fiercepharma.com

Given the huge body of evidence that the decline in the use of anti-depressants has fueled an increase in suicides, the fearmongers now blame an increase in the use of anti-psychotics. That includes David Healy, the well-paid expert witness for trial attorneys now suing the likes of Eli Lilly who make...anti-psychotics.

Can we say conflict of interest?

Where will Healy, David Graham and the rest go to wash the blood off their hands? And will the FDA do the right thing and stop handing black boxes out to protect themselves from Senator Grassley and the press?  Read More & Comment...

VA Patients in Peril

09/06/2007 09:06 AM |

Hillary, Obama, Edwards, et al still continue to point to the VA system as a model for how to handle prescription drugs. Let it be noted that Lipitor is not on the VA formulary and patients are usually started out on a generic statin. Now cut to the following headline:

From The Times (UK)
September 6, 2007

Switch to cheap statins 'raises risk of heart attack or stroke'

Report on risk research undertaken by maker of the market leader in branded statins
Nigel Hawkes, Health Editor

Millions of patients being transferred to cheaper generic versions of statin drugs may suffer a greater risk of heart attacks and strokes, a study says.

Patients in Britain who have been prescribed branded statins such as Lipitor or Crestor are being switched by their GPs to a cheaper drug, simvastatin, to save money.

The claim is that simvastatin is similar in its effects to Lipitor, the market leader in branded statins, so that nobody will suffer by the switch and the NHS will save tens of millions of pounds a year.

Pfizer, which makes Lipitor, investigated whether such switches were really risk-free by using an NHS data-base compiled from GP data.

It reported yesterday at the European Society of Cardiology Congress in Vienna that patients switched from Lipitor to simvastatin had a 43 per cent higher chance of a major cardiovascular event, such as a heart attack."

And here's the key point that liberals and the comparative effectiveness crowd willfully ignores explaining why stroke and heart attack rates were up:

"One possible explanation, he said, was that statins are actually different in their effects. The sample, of 2,511 people who had been switched, did not show any difference in the level of “bad” LDL cholesterol, but relatively few GPs had recorded the data.

“We only have that data for 15 per cent of the sample,” Dr Phillips said. “Maybe if we had more it would show that switching leads to higher LDL levels, which could help explain the findings.”
Previous head-to-head comparisons of statins had shown that the choice of drug had little effect on death rates, he said, except in very high-risk patients.

The differences tended to be seen in morbidity, he said: how ill people were and how well their symptoms were controlled."

And that's the model the know-it-alls want to shove down the throats of the rest of us.

http://www.timesonline.co.uk/tol/news/uk/health/article2395284.ece  Read More & Comment...

New Cure for Depression: Fear

09/06/2007 08:31 AM |

According to a new study, the rates of diagnosis and treatment of depression among adults have declined significantly since the FDA's warning about the possible risk of suicide among teens when they're treated with SSRIs.

"While some degree of decline in antidepressant prescribing was not unexpected after the black box warning was issued, few if any had predicted diagnosing to decline, or that other modes of treatment (psychotherapy or other medications) would remain relatively unchanged," Dr. Robert J. Valuck told Reuters Health. "It was thought that the latter two may increase to compensate for fewer antidepressant prescriptions being written."

That's worth repeating -- the black box warning has resulted in a decline not only in prescribing (no surprise there) but in diagnosis.

Does this meant that we can rid our nation of depression via fear of pharmaceuticals? That's a pretty frightening proposition.

Valuck, from the University of Colorado at Denver, and colleagues examined data relating to depression among 400,000 adult patients enrolled in managed care plans.

Hmm -- "in managed care plans." Is cost once again trumping care? Or is depression really one of those "made-up" diseaese we're reading about so much these days?

In the five years before the SSRI warning about teen suicide, the rate of diagnosed episodes of depression increased steadily from 6 to 11 per 1000 enrollees, the investigators report in the American Journal of Psychiatry.

The percentage of patients who had at least one psychotherapy session, and the percentage of depressive episodes for which possible alternatives to antidepressants were prescribed, did not change significantly after the advisory, the researchers found.

"We believe that there are likely to be many factors involved in the changes that we observed, and that they are very deserving of further study," Valuck said. "Physicians and policy makers should be aware of the power of these regulatory tools, both for the intended and unintended consequences that they may cause."

Did somebody say "unintended consequences?"

Indeed, let's not forget that in the June issue of the journal PLos Medicine a study reported that rather than boosting suicide rates, SSRIs have actually saved thousands of lives by preventing suicides since they were introduced in 1988.

For this study, the authors analyzed federal data on suicide rates since 1960, along with sales of fluoxetine (Prozac) since it became available in 1988. Analysis was continued through 2002. Prozac was used as a benchmark for the broader class of drugs.

Between the early 1960s and 1988, suicide rates held relatively steady, fluctuating between 12.2 per 100,000 and 13.7 per 100,000.

Since 1988, however, suicide rates have been on a gradual decline, with the lowest point being 10.4 per 100,000 in 2000. During the same time frame, Prozac prescriptions rose, from 2,469,000 in 1988 to 33,320,000 in 2002.

Using mathematical modeling, the investigators estimated the rates of suicide if the pre-1988 trends had continued, estimating that there would have been an additional 33,600 suicides if the pre-1988 trends had been maintained.

With that in mind, moves to restrict the use of SSRI antidepressants could have a harmful effect, the authors stated.

“I don’t think these claims that antidepressants increase suicide have a solid base,” said Dr. Julio Licinio, lead author of the study and Chairman of the Department of Psychiatry and Behavioral Sciences at the University of Miami.

“If you have a drug that’s supposed to be causing something, the more of the drug that’s used, the more of the bad outcome you would have. What we show is the converse.”

But, hey, if we just stop diagnosing the disease, then the problem will go away all by itself, right? Wrong!

This should serve as another wake-up call to those who applaud the wholesale expansion of FDA black box warnings.  Read More & Comment...

New England Journal of Moaning

09/05/2007 06:51 PM |

The NEJM can't get over the fact that the FDA Adcomm ignored their wizened advice and Steven Nissen/their best efforts to get Avandia canned, so on the heels of the incredibly inaccurate and whiny article by Jerry Avorn, it publishes yet another screed by Sheila Smith about how the FDA has failed to respond to the IOM recommendations -- which of course were made by Bruce Psaty, David Blumenthal and Sheila Burke.

Let's remember at the Avandia meeting David Graham used meta-analysis and unpublished data from an observational study that did not have safety as a primary endpoint to remove a drug. I guess that's what Sheila Smith means in her article about giving safety staff a strong voice.

http://content.nejm.org/cgi/content/full/357/10/960?query=TOC  Read More & Comment...

Kernels of Wisdom?

09/05/2007 06:09 PM |

I am not making this up ... Yet another example that proves my point that we are so bored, risk averse, and unwilling to take personal responsiblity that we clear the field for so-called public health advocates to blame lung disease on popcorn.

Doctor warns consumers of popcorn fumes

"Consumers, not just factory workers, may be in danger from fumes from buttery flavoring in microwave popcorn, according to a warning letter to federal regulators from a doctor at a leading lung research hospital."

But only if you have 12 bag a day jones for the stuff. Or at least the smell of burning kernels in your nostrils.

"(T)he ailing patient, a man whom she wouldn't identify, consumed "several bags of extra butter flavored microwave popcorn" every day for several years.

He described progressively worsening respiratory symptoms of coughing and shortness of breath. Tests found his ability to exhale was deteriorating, Rose said, although his condition seemed to stabilize after he quit using microwave popcorn.

She said her staff measured airborne levels of diacetyl in the patient's home when he cooked the popcorn. The levels were "similar to those reported in the microwave oven exhaust area" at the quality assurance unit of the popcorn plant where the affected employees worked, she said."

Similar to a microwave oven exhaust area? Did this guy even stop scarfing popcorn to go to the bathroom?

The article discusses "exposure to diecytl" as the culprit. Sounds horrible right? Until you read the CDC and NIOSH findings suggesting either a tenuous link or "ventilation" as the right response. Is exposure related to increased risk of irreversible lung disease? Enough to cause lawsuits a'poppin.

Coming to a store near you. Black box warnings on the package of microwaveable popcorn.

http://news.rgj.com/apps/pbcs.dll/article?AID=/20070905/FOOD/709050313  Read More & Comment...

Original THIN

09/05/2007 09:00 AM |

News from today's meeting of the European Society of Cardiology Congress 2007 (also in The British Journal of Cardiology) -- An observational study of a large United Kingdom primary care database showed that patients who were switched from established Lipitor therapy to generic simvastatin experienced a 30% increase in relative risk of cardiovascular events or death compared to patients who remained on Lipitor therapy.

The study was conducted by, among others, scientists from Pfizer.

The data, which included records from October 1997 to June 2005, were generated from a retrospective analysis of a medical database of anonymous patient records entered by general practitioners in the United Kingdom known as The Health Improvement Network (THIN).

The analysis included 11,520 patients (2,511 patients who had taken Lipitor for six months or more and were switched to simvastatin vs. 9,009 patients who were taking Lipitor for six months or more and then remained on Lipitor therapy).

While the reasons these patients were switched is not known -- it is certainly not inconceivable that it might have had something to do with ... short term costs to the system. Another example of cost-based medcine trumping patient-centric care.

“Today, many health care payors including governments and managed care companies are encouraging patients who are well-established on one therapy to switch to a different statin therapy,” said Dr. Michael Berelowitz, senior vice president of Pfizer’s global medical division. “This study raises concerns about those policies. It suggests the potential for poorer cardiovascular outcomes associated with switching patients from established Lipitor therapy to simvastatin.”

A secondary analysis of the same data showed that patients who were switched from Lipitor to generic simvastatin were more than twice as likely to discontinue their treatment compared to those who remained on Lipitor therapy (20.5 percent versus 7.62 percent, p<0.001). The reasons for discontinuation were not available from the database, though disruption in treatment has been associated with poor adherence in previous studies of statins and other medications.

And we strongly support Dr. Berelowitz's statement that, “Observational studies help the medical community better appreciate what is really happening in doctors’ offices, and are commonly used by healthcare payors to set medical practice guidelines. This analysis highlights the need to carefully consider individual patient circumstances and cardiovascular risk because indiscriminate switching may adversely affect some patients.”

Here is a link to the poster presentation:

Download file

Power to the Physician! Power to the Patient! THIN is in.  Read More & Comment...

Drug Money? You Don't Say!

09/05/2007 08:27 AM |

Whose giving what to whom? Well, since you asked ...

According to the Institute for Health and Socio-Economic Policy, the research arm of the California Nurses Association/ National Nurses Organizing Committee (CNA/NNOC compiled the research report in concert with the release of director Michael Moore's SiCKO, so consider the source), Democratic and Republican presidential candidates have accepted more than $3.7 million in campaign contributions this year from health-care industry sources, with more than 45% of the money going to just two candidates, Senator Hillary Clinton, D-N.Y., and former Massachusetts Governor Mitt Romney. Overall, health-care contributions to the 18 announced Republican and Democratic presidential candidates total an aggregate $12.8 million since 1989--with 29% of that total donated just in the first quarter of 2007.

Ms. Clinton topped the recipient list with $868,722, which is 23% of all the health-care money donated to candidates this year. Mr. Romney was a close second at $833,385, which is 22% of the total. Senator Barack Obama, D-Ill., received 15% of the total, or $574,268; Senator John McCain, R-Ariz., received 11%, or $423,751; former New York Mayor Rudy Giuliani also received 11%, or $408,822; and former Senator John Edwards received 6%, or $222,950.

For more on this and come choice comments on SiCKO, click on this link:

Download file

And, remember -- it's not what you say ... it's what you don't say.  Read More & Comment...

Another Question To Ask Miss South Carolina

09/04/2007 04:10 PM |

Adult women are more than twice as likely to know how much they weighed in high school as they are to know their current cholesterol number, and only half of women have had their cholesterol tested in the past year, according to the results of a nationwide survey released today.

Why do you think this is?

Here's a link to an article about the study

http://www.news-medical.net/?id=28935

And for the clueless and cave dwellers here's a link to the infamous Q and A with the young lady who is the most famous person in US/America, at least for now.

http://www.youtube.com/watch?v=lj3iNxZ8Dww  Read More & Comment...

Another Body Blow to Comparative Effectiveness

09/04/2007 11:26 AM |

First research comes out showing that women need different treatment than men for heart disease. Then a study comes out show thousands of new lung cancer tumors -- with unique subgroupings based on pathogenesis -- will extend treatment to thousands. Now this from the Venter Institute a new genome sequence refining and identifying more precisely that humant to human variation in response to disease and medicines.

Why does the Agency for Health Care Qualty and Research still spend a dime on dross from the Drug Effectiveness Research Project which does nothing but catalogue outdated data? Why would the Bush Administration pave the way for single payer health care with a one size fits all coverage decision on blood boosting drugs that will be used differently in differnt people?

Do insurance companies really think they are going to get a comparative effectiveness board of the ground in the face of the individualizaation of medicine?

Comparative effectiveness is rationing in health economist clothing. To suggest it promotes "best practice" (Hillary) or increases value to the patient are ignoring the rapid changes in medical science and the heavy handedness of their own methods which are driven more by a hatred of drug companies than a concern for patients.

I woud be happy to debate anyone, anytime, anywhere on this subject. But I don't think they (and they know who "they" are) will. Because they are not interested in advancing well-being because it will obviously lead to an increase in the use of most new drugs and devices. They are interested in legislative victories and cost containment in the short term.

For more info about the Venter breakthrough go to http://www.JCVI.org.  Read More & Comment...

ALLHAT Trick

09/04/2007 08:10 AM |

In his recent Wall Street Journal op-ed, Scott Gottlieb reveals how government-run comparative studies reflect a desire to focus on cost rather than care – and not (as often claimed) to usher in an era of science-based efficiency in medicine.

The Center for Medicine in the Public Interest recently held a conference on large scale comparative effectiveness studies. (Report can be found at http://cmpi.org/archives/2007/08/new_cmpi_report.php) As Gottlieb mentioned, one government study (ALLHAT) didn’t prove its hypothesis that older drugs are more effective in controlling blood pressure.

At the CMPI conference Dr. Michael Weber (an original member of the ALLHAT team) revealed that “ALLHAT exposed African-American patients for several years to treatments investigators knew would not be effective in controlling their blood pressure -- something so unethical that if a pharmaceutical company had done it or any of us as individual academics had done it, we would not only be thrown out of our jobs, we would be pilloried and maybe even be facing criminal charges. The study was driven entirely by a 40% excess stroke rate in black patients that was predictable before the study began. And they used that as their reason to claim superiority of the diuretic.”

The government ran a study denying African Americans needed care to make a political point: cheaper drugs are better. Because ALLHAT is perceived as anti-industry no one cares if the regimen harms people. Is this the kind of comparative effectiveness we want – or that patient’s need?  Read More & Comment...

Mind numbing reporting on bipolar kids

09/03/2007 09:37 PM |

I am sure the black helicopter types who believe drug companies are actually colluding in ways to medicate children for mental illness...but is there any self-respecting psychiatrist who would actually fit this statement from an AP article on the increase in diagnoses for pediatric manic depression.

"Some doctors believe bipolar disorder doesn't occur in children, and until last month there was only one drug approved to treat the illness in kids."

The reporter never identifies those scholars. And then to link this statement with the fact that most pediatric drugs are used off-label. (Better to treat and observe than use kids as lab rats)

Yeah, and there are no drugs approved to treat stomach cancer in kids but they use them anyways.

Here's the entire article:

http://news.yahoo.com/s/ap/20070903/ap_on_he_me/bipolar_kids_3  Read More & Comment...

Meet me at the corner of Information and Engagement

08/31/2007 02:01 PM |

If you decided to use MapQuest for directions to better drug safety ideas, it might very well direct you to the intersection of Information and Engagement.

Nowhere is this made more clear than with a new program called iGuard. According to their website (http://www.iguard.org):

"iGuard is the fastest and easiest way for you to get personalized alerts and updates on the safety of your medicines.

We are the catalyst for the new conversation among patients, physicians, pharmacists, drug researchers and the government. Launched in 2007 as a startup venture funded by Quintiles Transnational, "iGuard puts the power of drug safety in the hands of each American, right where it should be," states Dr. Hugo Stephenson, founder and president of iGuard.

We facilitate the virtual flow of communication among patients, physicians, and researchers according to two guiding principles:

With iGuard, patients can feel safer because they will be sent the drug safety information they need, when they need it.

The more people that join iGuard, the faster we can help researchers identify safety problems - and communicate this information back to patients, caregivers, and their providers."

It's worth a look -- because it provides a hopeful glimpse into the future of drug safety.

I have seen the future -- and it is collaborative.  Read More & Comment...

CATIE Bar the Door

08/30/2007 10:00 AM |

And ALLHAT Jazz too.

Important op-ed by Scott Gottlieb in today's Wall Street Journal on the continuing jihad against incremental innovation via poorly designed studies and slanted reporting thereof.

As Scott writes:

"The difficult nature of these "comparative" drug studies, the sort contemplated in Schip, requires more care, not less. These studies are hard to execute by their nature, a fact given short shrift by policy makers who believe the conclusions gleaned from the research will provide immediate cost savings.

For one thing, as the Allhat study proved, detecting small clinical differences between two active drugs, such as whether one pill lowers blood pressure more than another, requires very large studies that often fail to capture all of the patient preferences and characteristics that go into real world medical decisions. And once the study is completed, determining whether small differences are clinically meaningful can take years of follow up.

When the trials are under-funded and too small, or are poorly designed or conducted, important differences are not detected, which supports the theory that older drugs are as good as newer ones even if that is not true. This flawed science seems just fine with those who support these trials largely for cost purposes."

And many top clinical experts agree. Click on the link below and see what Hebert Meltzer, MD who helped to design CATIE, Michael Weber, MD, similarly involved with ALLHAT, Dr. Susan Horn of the Institute for Clinical Outcomes Research, Dr. David Shern, President and CEO of the National Mental Health Association, Ralph Snyderman, MD of Duke University have to say on the topic.

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No matter how you cut it, evidence-based medicine based on bad evidence is bad medicine. This language disintermediates physicians, hurts patients and helps nobody other than payors (both public and private).

And that's not public health -- it's politics  Read More & Comment...

Social Marketing 101

08/29/2007 07:10 AM |

Here's a really superb example of health care grass roots "social marketing" -- made all the more exciting since it bubbled up all by itself ...

http://nocnews.blogspot.com/2007/08/healthcare-prescriptions-and-insurance.html

And in case you cannot link to the Pharmaceutical Executive article mentioned there, here's a better link ...

http://cmpi.org/archives/2007/08/opinion_fewer_cents_more_sense.php

(And, yes, it's the same Nazareth that's in The Band song "The Weight.")

Pulled into Nazareth ...   Read More & Comment...