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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?
(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.
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
This file requires Adobe Reader. Click Here to download Adobe PDF Reader.
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
This file requires Adobe Reader. Click Here to download Adobe PDF Reader.
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.
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.
