Latest Drugwonks' Blog
Apt because of his excellent new article, "Drug Safety, medication, safety, patient safety: An overview of recent FDA guidences and initiatives."
Rick's article can he found here.
His abstract sets the stage:
"Drug development and pharmacotherapy are components ofintegrated pharmaceutical medicine. The term ‘drug safety’ canbe used when evaluating adverse events during clinical trials, andwhen evaluating adverse drug reactions to a correctly prescribed, dispensed and administered drug. The term ‘medication safety’ refers to the evaluation of medication errors that occur at the prescribing, dispensing and/or administration level; endeavours to educate clinicians and patients about the correct use of a particular drug; and the design and implementation of safety systems and educational programmes to minimise these errors. Drug safety and medication safety are subsets of patient safety.Recent guidance documents and initiatives at the US FDA indicate the agency’s awareness of the paramount importance of safety considerations throughout drug development and pharmacotherapy, its commitment to expand and enhance its governance role in lifecycle drug development, and its commitment to play an infl uential role in the safe use of medicines."
Turner's discussion of REMS, safe use, FDAAA, the Sentinel initiative, and other important items makes this article a must read.
They don't call him "Page" Turner for nothing.
The other group of people were of course not the clueless in the mainstream media. They were the audience the President of Iran played to by speaking -- on Hitler's birthday at a UN sponsored conference on racism rigged to engender more hate and promote the destruction of the Jewish state. As Ahmadinejad spoke European delegates to this conference on racism walked out in protest. Yet many of their own countries were party to cancelling Holocaust Remembrance ceremonies in various cities to "protest" Israel's military operation in Gaza in response to both rocket attacks and it's continuing project of establishing medium and long range missle capacity against major cities in Israel, courtesy of Iran. The irony of siding with those who eliminate the Jewish state as a form of protest was lost on these nation states. Similarly, the willingness to abet militant Islam in meaningless international conferences and expect to be congratulated for walking out on the speech of a monster...well now that I think about it, that's something the students at Columbia University didn't do!
Once again history and the future of the Jewish people appear to be on a collision course. Throughout the world lip service is paid to our "right to exist", as if this is some sort of special gift from the family of nations and not something Jews -- mostly Israelis in the past 60 years -- have had to defend with their lives almost yearly. The promise of "Never Again" is uttered but in Europe and in the the halls of Congress and the mainstream media, attacks on the Jewish lobby are now part of the conversation. Modern day blood libel (the Gaza operation) is now the grist for playwrights who explore the Jewish soul and conclude it is dark, violent and racist to the core. England has become a cesspool of anti-Semitism and many in the American left are following suit. Sometimes I fear the world is slouching from indifference back to eon-old habits.
Yet I believe Israel will prevail and the Jewish people will thrive precisely because of day's such as this one. In Israel at 10 am sirens wailed, traffic stopped, people stood still. For a minute the entire nation as one remembered, not just as a collective reminder of what preceded the establishment of Israel, but to show that one nation carved out of national tragedy will eternally bear witness to both the evil that nearly consumed the world and to our capacity not only rouse the conscience of others but to defend our existence the next time such evil rises again. We pause in silence. Not just to remember, but to underscore our willingness to set aside "normal" life and do what is required to survive, thrive and contribute to the world.
It is 10:01 am. Life in Israel goes on. Am Yisroel Chai.
The theory is that the way to make drugs “safer” is to ensure they are used appropriately.
And communications is the weak link in the chain. Hence REMS as a tool for safe use. Seems to make sense.
Presented for your consideration -- questions posed by the FDA in advance of a two-day public meeting set for May 27-28 on whether class-wide opioid REMS should include a certification process for prescribers, pharmacists and other heath care providers, a strong patient education component, and prescriber-patient agreements.
According to a report in the Pink Sheet, “Since FDA's announcement that it intended to seek the class-wide REMS in February, pharmaceutical companies have been charting new territory as they try to work together to develop a REMS framework for the whole class.”
Working together to advance safe use. Good idea. The Pink Sheet continues, “The evolution of the opioid class-wide REMS will set an important precedent for trying to get competitors to work together on post-marketing programs in the future.”
In short, competitors must also be allies in pursuit of the public health. And that means both innovator and generic companies.
Not easy. But important advances rarely are.
The President has recently reaffirmed his conviction that "we must have quality, affordable health care for every American.” This is an important goal. In the health care debate, though, misconceptions abound — and this hurts reform efforts. As lawmakers move forward, they must be aware of the facts. And they must be clear on the precise causes of
The American health care system is broken in important respects. American health care is designed to provide acute care, but too often neglects the urgent imperative of chronic conditions. This disconnect will become even more problematic as Baby Boomers continue to age and the fastest growing demographic segment in America is the over-75 population. The argument that health care is "too expensive" is too broad. A better argument is that waiting until Americans become seriously ill to intervene is too expensive. Earlier diagnosis and earlier, continuing care is crucial to the future health of both Americans and the American health care system.
Prevention must be our first line of defense. Our health care system often works miracles when people become very ill, but it needs to do a better job at keeping people healthy before disease attacks. Although proper diet and nutrition are misunderstood and undervalued, better health care habits will not prevent the diseases that all Americans (and Baby Boomers in particular) will develop as we age. There are effective treatments, including medicines, which stop diseases such as hypertension and diabetes from progressing, allowing millions of Americans to lead active and productive lives rather than undergoing surgery, emergency care, hospitalizations, disabilities, and nursing home care.
We cannot afford, in terms of either dollars or lives, to continue playing the health care "blame game," tending to focus on health care prices - for hospitals, insurance, drugs, and doctors. Disease is the enemy and the cost of disease is staggering. Rather than looking for a villain, it's time to start asking the hard questions and finding the right answers - focusing on how to reduce the price of a diabetic amputation is the wrong approach. We need to focus on prevention because that's the best way to save money and improve lives. Now is the time to do this, so that we can invest in and afford better treatments for other conditions such as cancer and Parkinson's disease, which are so desperately needed and that hold so much promise.
All Americans deserve access to quality health care, but how can Americans get broader access to health care without diluting the quality of health care and compromising the future of health care? If miracles have become expectations - "What's a miracle worth?"
For the rest of the story, see here.
Comparative effectiveness research might lead to people being denied life saving care but at least they would get to choose the music they die to...free of charge I hope....
Hallelujah or Highway to Hell? Songs to die for
AFP/File – US entertainer Frank Sinatra sings in Washington, 1992. Sinatra's "My Way" is the most …
LONDON (AFP) – Frank Sinatra's "My Way" is the most popular song played at funeral services, but other more arresting death-bed choices were revealed in a poll published in Britain Thursday.
Australian rockers AC/DC's "Highway to Hell" has stormed into the funereal charts along with Queen's "Another One Bites The Dust," while Leonard Cohen's "Hallelujah" has a new lease of life after its recent success on a talent show.
More traditionally, hymns including "The Lord Is My Shepherd" and "All Things Bright And Beautiful" are among music chosen by people to accompany their final journey.
For classical music fans, Schubert's "Ave Maria," Puccini's "Nessun Dorma" and Bach's "Air On A G String" are among the most chosen pieces to comfort their loved ones as they pay final farewells.
Television and radio music also features on the burial playlist: theme tunes from popular programmes like "Top Gear", "The Benny Hill Show" and even the Radio Four Shipping Forecast music, which many fall asleep to at night.
Click Here to Read the Full Article
To read this piece in its entirety, click here.
Stop the presses. This just in from the Gray Lady: Genomics is hard.
The Times continues, “One issue of debate among researchers is whether, despite the prospect of diminishing returns, to continue with the genomewide studies, which cost many millions of dollars apiece, or switch to a new approach like decoding the entire genomes of individual patients.”
Specifically, “A set of commentaries in this week’s issue of The New England Journal of Medicine appears to be the first public attempt by scientists to make sense of this puzzling result.
But the Times story is somewhat misleading. The NEJM articles aren’t about molecular diagnostics (Herception, Warfarin, etc.) but rather the attempt by some companies “to offer personal genomic information” that would offer customers specific genetic risk for common diseases.
That’s something else entirely. In fact, it's what confuses people (meaning "people" but also "journalists" and "politicians") about what “personalized medicine” is all about.
The unintended (one hopes) consequences of articles such as the one in the New York Times and the commentaries in NEJM are that the important momentum behind pharmacogenomic research gets slowed – along with all-important funding for same. Case in point: how will this article play in the battle to fund the FDA's Reagan/Udall Foundation?
Alas, there is no magic bullet. Frustrating? Sure. But anyone who thought it was going to be easy wasn't paying attention. But hype is like that -- you want to believe it. Just because alluring promises of a personalized genomic map aren’t panning out doesn’t mean that genomics aren’t the most crucial pathway forward for 21st century medicine and the roadmap in achieving the four rights (the right medicine for the right patient at the right time in the right dose).
The complete New York Times article can be found here.
Such misunderstandings also play into the hands of those who believe that the only way forward is through 20th century comparative effectiveness. And this is why we need a robust critical path for 21st century clinical effectiveness measurements.
Please join the Honorable Anna Eshoo, (D-CA.) Vice Chair, 21st Century Health Care Caucus former Congressman Mike Ferguson (current Senior Fellow, CMPI), former NFL linebacker Elijah Alexander, President, Tackle Myeloma Foundation, and other special guests at the inauguration of this timely and important project
CMPI created the Odyssey Project because we believe that medical technology is a not a costly burden to be contained, but the solution to humanity’s greater challenges. The Odyssey Project will provide a forum to discuss how medical progress has added to the health and wealth of families over the past half century, create a roadmap to insure it generates tremendous near and long-term prosperity and offers patient-centered prescriptions for America’s health care crisis.
Please RSVP to Meryl Reichbach: mreichbach@cmpi.org or 212.417.9169
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.
