Latest Drugwonks' Blog
A urine test could help doctors decide which drugs will be most effective for their patients, scientists have shown.In trials the test predicted how well men would respond to paracetamol. The experts from Imperial College London and the drug giant Pfizer report their findings in Proceedings of the National Academy of Sciences.
The researchers say this kind of "metabolic profiling" could ultimately allow doctors to work out perfect drug matches for individuals, with no risk of side effects. "Pre-clinical studies had suggested it might be possible to predict how individuals would react to drugs by looking at their pre-dose metabolite profiles, but this is the first time that anyone has been able to show convincingly that such a test could work in humans.
"The beauty of the pre-dose metabolite profiling is that it can tap into both genetic and environmental factors influencing drug treatment outcomes."
The full BBC story can be found here.
When I was asked to advise President Obama’s FDA transition team, some of the smartest questions came from Alta Charo. Now she can ask even smarter questions from the inside. Starting on August 31st, she’s joining FDA as a senior advisor, reporting to Assistant Commissioner for Policy David Horowitz.
Charo (a professor of law and bioethics at the
Charo told colleagues in
See what Lou Dobbs has to say -- with some help from your's truly.
Click here ... and watch where you sit.
Here's a link to the short segment.
Not fatigued -- empowered!
As an antidote to the American media’s near-myopia about health care in considering the UK and Canada the only foreign countries with any relevance (which has abated somewhat but not nearly enough), some health care headlines from elsewhere in the world.
In Germany, in new poll by the Allensbach Institute indicates that the population is concerned about two-class medicine, with 72 percent of participants saying they are concerned that patients with private insurance get better treatment than those in the public system. And 80 percent of doctors say they don’t have enough time with patients to complete everything they need to.
Further, public sickness funds face deficits next year that are estimated at between 7 and 11 billion euros. Special “ancillary premiums” are likely to be charged by the sickness funds at some point this year and the insurers are seeking, unsuccessfully so far, more money from the government.
In France, the coffers of the national health care system are 9.4 billion euros in the red and conservative politicians there have been making ominous pronouncements about the future of the Sécurité Sociale system as a whole.
In Switzerland, health care premiums could rise up to 20 percent next year. A poll found that some 30 percent of people there may switch insurance companies if premiums go up 10 percent, some 43 percent if they increase 15 percent, and a majority will move to a cheaper company if the rise is indeed 20 percent. In addition, 58 percent say they are against the 30 Swiss franc (~$27) co-pay for visits to the doctor.
Deficits, co-pays, and too short consultations with the doctor. If this all sounds familiar, it should. The US isn’t alone in its problems and no system is perfect, all make trade-off with regard to what they cover and what they cost. All three of the above systems are either private or public-private hybrids that bear lots of similarities to the US system –and to American reform proposals, making it clear that no matter what the outcome of the bills now before Congress, the challenges the US faces aren’t going to magically melt away.
There are no panaceas in either policy or medicine and those who believe there are have been duped. The lesson is clear: look before you leap –and look carefully.
That's a loss.
Dan's smart, feisty, and calls it like he sees it -- a trait that has often put him at odds with lesser mortals.
And he's a nice, decent guy. Two traits often in short supply.
Good luck and God's Speed Dan Schultz.
It seems now that another company, Amphastar Pharmaceuticals, isn't satisfied with patent litigation as its weapon of choice. Unsatisfied with the way the FDA is dealing with their file for generic Lovenox, they've achieved new lows by attempting personal intimidation tactics. It won't work.
They're slinging mud. It will only come back to splatter on their own reputation.
Amphastar claims that its rival, Momenta, has a "leg up" and is getting "special access." And yet both companies are in the same place in the regulatory process and both companies are being asked for the same data sets. And this is unfair why?
According to Amphastar it's unfair because CDER Director, Dr. Janet Woodcock co-authored a paper with one of Momenta's founders, MIT biological engineering professor Ram Sasisekharan, on how the FDA taskforce (on which they both served) identified and contained the cause of contaminated Chinese heparin imports.
Talk about desperate measures.
"His approval ratings slipping, President Barack Obama is retooling his message on health care overhaul, aiming to win over Americans who already have insurance."
Wait a minute. I thought the goal of reform was to cover people who did not have insurance and couldn't afford it or were denied coverage. Shouldn't the proposal be retooled as opposed to the message?
"Republicans say the heated debate is a sign of widespread public dissatisfaction with Obama's ideas. But with some of the anxieties spilling into angry disruptions and even threats, Democrats have accused Republicans of orchestrating the events to sabotage legislation. In an article published Monday, House Speaker Nancy Pelosi and Majority Leader Steny Hoyer wrote, "Drowning out opposing views is simply un-American."
Obama and his aides stayed away from such provocative language"
Right, they just set up a government website to collect information about political opposition and promising congressional Democrats that they would "punch back twice as hard" against opponents. http://www.politico.com/news/stories/0809/25891.html
Do they address the major flaws and impact of every proposal on the table.
No.
Last night CBS News reported, "When he was running for President, Barack Obama attacked pharmaceutical companies for charging too much for prescription drugs. But now he's teamed up with those same companies to promote his healthcare plan," and critics are accusing President Obama "of making a back-room deal that could end up costing seniors plenty." CBS added, "Initial reports said the White House agreed not to seek price controls on drugs for seniors on Medicare and would not support importing cheaper drugs from
So, no deal?
But on August 5th, the New York Times ran a front page article headlined,
"White House Affirms Deal on Drug Cost.”
It read in part,
So, deal?
Simple yes-or-no question: Does the President support "the deal" or does he not?
We have taken great pains to distance ourselves -- and those individuals who have attended town hall meetings of their own volition -- from the handful of individuals and one or two nut jobs who sought to shout rather than ask tough questions even as certain poitical operatives have sought to lump us, them and all into one seething hateful mob.
That is politics as usual.
But the editorial today by Speaker Pelosi and House Majority Leader Hoyer -- mostly unmentioned by the same media who covered the handful of angry Americans as if they were the vanguard of some neo-Bund movement -- calling those who assemble and organize against a misguided effort to increase government control over healthcare as "unAmerican.
Here is the key quote:
"An ugly campaign is underway not merely to misrepresent the health insurance reform legislation, but to disrupt public meetings and prevent members of Congress and constituents from conducting a civil dialogue. These tactics have included hanging in effigy one Democratic member of Congress in Maryland and protesters holding a sign displaying a tombstone with the name of another congressman in Texas, where protesters also shouted "Just say no!" drowning out those who wanted to hold a substantive discussion.
Let the facts be heard
These disruptions are occurring because opponents are afraid not just of differing views — but of the facts themselves. Drowning out opposing views is simply un-American. Drowning out the facts is how we failed at this task for decades."
Those who oppose or criticize are part of an ugly campaign to drown out opposing views and suppress the facts. Thus we are unAmerican.
Have you been or are you now part of any campaign to oppose health care reform. If so, you are drowning out the facts. And if you were oppose health care reform you obviously endorse hanging opponents in effigy.
I think the exchange between Joseph McCarthy and Joseph Welch sums up the tactics and desperate moral compass of Ms. Pelosi and Mr. Hoyer with respect to enacting single payer healthcare reform. I can't generalize to anyone else ...
http://en.wikipedia.org/wiki/Joseph_N._Welch
On June 9, 1954, the 30th day of the hearings, McCarthy accused Fred Fisher, one of the junior attorneys at Welch's firm, of association (while in law school) with the National Lawyers Guild (NLG), a group which J. Edgar Hoover sought to have the U.S. Attorney General designate as a Communist front organization (see Army-McCarthy hearings). Welch wrote off Fisher's association with the NLG as a youthful indiscretion and went after McCarthy for dragging the young man's name before a nationwide television audience with no prior warning or previous agreement to do so:
- "Until this moment, Senator, I think I have never really gauged your cruelty or your recklessness. Fred Fisher is a young man who went to the Harvard Law School and came into my firm and is starting what looks to be a brilliant career with us...(L)ittle did I dream you could be so reckless and so cruel as to do an injury to that lad. It is true that he will continue to be with Hale and Dorr (Welch's law firm). It is, I regret to say, equally true that I fear he shall always bear a scar needlessly inflicted by you. If it were in my power to forgive you for your reckless cruelty I would do so. I like to think that I am a gentle man, but your forgiveness will have to come from someone other than me."
When McCarthy tried to go on the attack once more, Welch stepped in again and famously rebuked:
- "Senator, may we not drop this? We know he belonged to the Lawyers Guild...Let us not assassinate this lad further, Senator. You have done enough. Have you no sense of decency, sir? At long last, have you left no sense of decency?"
McCarthy tried to ask Welch another question about Fisher, and Welch cut him off:
- "Mr. McCarthy, I will not discuss this with you further. You have sat within six feet of me and could have asked about Fred Fisher. You have brought it out. If there is a God in Heaven it will do neither you nor your cause any good. I will not discuss it further. I will not ask Mr. Cohn any more questions. You, Mr. Chairman, may, if you will, call the next witness."
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.
