Latest Drugwonks' Blog
Center for Medicine in the Public Interest presents:
"Industry Support for Continuing Education of Healthcare Professionals"
Monday September 22, 2008
8:00am-12:00pm
121 Cannon House Office Building, Washington, DC
CLICK HERE to view the Capitol Hill event invitation
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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
Well, it ain’t free. Government-controlled healthcare is funded through (gasp!) taxes.
Consider
Then consider the United Kingdom, so often held up by advocates of "universal" healthcare.
“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.
He was diagnosed with multiple myeloma, a cancer of the blood cells, in May 2004. Doctors at the
Revlimid is readily available to patients in Europe and the
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."
* 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
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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/
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
A new study may bolster the argument that a drop in the use of antidepressants has led to an increase in teen suicides.
MAKING SENSE OF TEEN SUICIDE
How a trend changed direction.
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
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
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
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
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.
Fortunately the Critical Path does not require a visa -- but it does require funding -- now!
As you can see from the blog entry “What Depression, Measles and Sir Isaac Newton have in common”, there’s a new voice on drugwonks – Dr. Tim Franson.
Tim is a guy who, as the old Jewish joke goes, "knows where the rocks are."
His regulatory knowledge is nonpareil and his optimism is contagious.
"When the Food and Drug Administration approved a new type of cholesterol-lowering medicine in 2002, it did so on the basis of a handful of clinical trials covering a total of 3,900 patients. None of the patients took the medicine for more than 12 weeks, and the trials offered no evidence that it had reduced heart attacks or cardiovascular disease, the goal of any cholesterol drug."
Read New York Times article
Neither did any of the other clinical trials for any of the other statins.... So does that mean statins have not reduced heart attacks or CV disease? And PS, the study also showed that there was no risk of cancer, but you don't find that out until the end of the story. And in any event, not one story has investigated the complex relationship between lipid levels and cancer which has confounded and confused researchers for decades. Check out:
Read more here
Berensen then shifts to the Vytorin post market studies....which are focused on specific groups of patients, high risk groups that are genetically at risk for athersclerosis, aortic stenosis, etc.
The researchers in the SEAS study observe:
"The combination of simvastatin and ezetimibe resulted in an average reduction in LDL cholesterol of at least 50%, as compared with placebo. Despite this favorable effect over a minimum period of 4 years, there was no overall effect on aortic-valve stenosis and no significant overall effect on the composite primary outcome. The lack of any effect on the progression of aortic stenosis as seen on echocardiography supports the conclusion that the lack of effect on clinical valve-related events was real and not due to a lack of statistical power. The finding of increased numbers of incident and fatal cancers in the simvastatin–ezetimibe group, as compared with the placebo group, was unexpected and requires further exploration in trials of simvastatin and ezetimibe.
The lack of effect on aortic-valve stenosis is in agreement with the findings of the smaller Scottish Aortic Stenosis and Lipid Lowering Trial, Impact on Regression (SALTIRE) study, in which atorvastatin was used.34 The results of the Rosuvastatin Affecting Aortic Valve Endothelium (RAAVE) study (ClinicalTrials.gov number, NCT00114491 [ClinicalTrials.gov] ) indicated a favorable effect on aortic stenosis, but the study had a nonrandomized and open-label design, with comparisons of various categories of patients with aortic stenosis.39
Our study population did not represent all patients with aortic-valve stenosis, since high-risk patients with severe hyperlipidemia requiring active lipid-lowering treatment, known atherosclerotic disease, or diabetes mellitus were not included in order to allow for placebo treatment. This factor may explain the relatively low rate of progression of aortic-valve stenosis in our study, as compared with that in other studies."http://content.nejm.org/cgi/content/full/NEJMoa0804602?query=TOC
So Berensen, Nissen and Furberg (see below) ignore the fact that Lipitor also failed to reverse aortic stenosis. Perhaps Lipitor should be removed from the market too?
Here's Nissen, who by the way received money from Pfizer but not from Merck or Schering Plough
“The F.D.A. set the bar too low on the initial approval,” said Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic. “It would have been a lot better if the agency had said, ‘Show us that you do more than lower LDL a little bit, show us evidence of effectiveness.’ ”
Further, when the F.D.A. approved Zetia, several statins were already on the market, giving patients other options to lower their cholesterol. So the agency’s decision to approve Zetia without requiring larger trials is especially puzzling, Dr. Nissen said.
Lower LDL a little bit?"The combination of simvastatin and ezetimibe resulted in an average reduction in LDL cholesterol of at least 50%, as compared with placebo. "
How about lying a littlle bit?
Now of course a more measured and targeted reassessment of the LDL heart disease relationship does exist. It is ignored by Nissen (who has never done any basic or NIH funded research on CV disease and only does research when he can make money conducting clinical trials) and pursued by Eric Topol at Scripps Genomic Health:
http://content.onlinejacc.org/cgi/content/abstract/52/5/378
Topol is working on gene-based trials to develop new drugs and diagnostics to treat people at high risk of serious heart diseases in studies that actually measure disease progression.
But Topol, who did the heavy lifting on the Vioxx safety problem, only to be shoved aside by a media hungry Nissen, is too busy doing real science in the area of biomarkers. Unfortunately, the folks on the NY Time speed dial are bio-Luddites who prescribe longer, larger (wishful thinking on their part?) clinical trials for every new drug using whatever media trumped up danger de jour to justify this outmoded position:
'Dr. Curt D. Furberg, an epidemiologist and drug safety expert at Wake Forest University, said that before approving drugs the F.D.A. should require that drug companies conduct large trials on whether they reduce death and disease, except in rare cases where no alternatives exist. If the agency approves drugs without such data, that fact should be noted prominently on a drug’s label, Dr. Furberg said.
What he and others continue to willfully overlook is that the studies in question are designed to reduce particular types of heart disease in small groups of patients and when they miss the endpoint claim the drugs don't work at all, and use that as an argument for larger, longer trials for safety and effectiveness. Conjecture and opinion replaces solid science. Unless science moves faster to occupy the space the Bio-Luddites occupy on the Web, traditional scientific institutions and science-based approaches will continue to be under attack by the ignorant and angry elite.
On the surface, the disease states of depression and measles could not be more dissimilar. Measles, a viral infection usually afflicting children at an early age, is typically an acute, self- limited disorder with a striking skin rash easily recognized by trained health professionals, and effectively prevented by insidious conditions with periodic worsening which impact all ages (though most frequent in adult females) which have no visible signs on physical examination and are not amenable to primary prevention.
What these two medical entities share are the risk of serious complications if not properly managed - and their plight in the health policy arena as byproducts of the "law of unintended consequences".
As a result of concerns about alleged overtreatment of depression in adolescents and a suspected risk of suicidal ideation related to therapy - fueled by congressional hearings and media attention, with resultant restrictive labeling additions by FDA several years ago - antidepressant therapy in this population has decreased. Recent surveillance studies indicate that for the first time in a decade, the rate of adolescent suicide attempts has risen … whether this potential temporal relationship of "reduced use-to-increased suicide attempts" is valid does require more careful study to be validated, but it is tempting to speculate that some cause and effect link may be present.
Likewise, accusations of childhood vaccines (notably those containing mercurial preservatives) being associated with causing autism have frequently surfaced over the past few years. While extensive studies by WHO and other authorities have found no evidence of vaccines being associated with autism, this concern continues to be highlighted by very vocal congressional and media sources -- and seemingly has created a "parental flinch" resulting in the reduced prevalence of childhood vaccine use in some communities. In the past week, reports have come to light regarding an increased incidence of measles cases in the
In both situations, there is no question that the actions of those in Congress and the media were well-intentioned and taken based on their perspective of drug/vaccine safety issues being a priority concern.
However, as Sir Isaac
The public health would be better served by policy decisions in which [1] no decisions are made based on safety alone, with a reinforcement of thoughtful benefit-risk assessments being the platinum yardstick (as they are done at the bedside of any patient) and [2] decisions are coupled with appropriate follow-up monitoring to ensure that unintended consequences do not surface as a result of such recommendations - and if such do occur, to promptly revisit such matters using careful reconsideration, with corrective actions as warranted (just as physicians do in managing a patient's conditions over time). Such approaches would not diminish the attention given to new safety findings, but would encourage more balanced actions. Our vision skills are best when employing both eyes, and monocular outlooks on life often lead to blind spots -- our vision of health policy deserves similar insight.
During my medical career, I frequently heard sage faculty admonish trainees to understand their limitations and not to fall into the trap of "doctors playing God" -- the converse also holds true, for when influential policy gods play doctor, power trumps knowledge … in both such scenarios, accountability is lost and Newton's Third Law cannot be appealed. Kids deserve better.
A new study out of Harvard debunks the canard that DTC advertising causes a “Pied Piper” effect of patients marching en masse to their physicians demanding drugs they don’t need.
Reuters reports that, “Expensive advertising of prescription drugs directly to consumers may do little to encourage sales,
According to the report, even though companies spent an estimated $3 billion in 2005 on such ads in the
"People tend to think that if direct-to-consumer advertising wasn't effective, pharma wouldn't be doing it,"
The nonprofit Kaiser Family Foundation has come to similar conclusions in reports on direct-to-consumer ads.
In an April report the foundation found that 91 percent of adults surveyed had seen or heard advertisements for prescription drugs, but just one-third spoke to a doctor about a drug they saw advertised, and 54 percent of them got a prescription for a different drug.
Among doctors, 76 percent said they sometimes recommend a different prescription drug to a patient who mentions a drug ad and 5 percent said they frequently gave patients the drug.
Here is the complete Reuters story.
Stay tuned.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
