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Today Dr. Bob and I officially released the “Prescription for Progress” taskforce report on the Critical Path. More on this shortly, but here’s a taste …
Our keynoter, Dr. Andrew von Eschenbach, noted that the FDA was at a “strategic inflection point” in its history. All you hi-tech wonks out there will no doubt be familiar with that phrase and it’s coiner — another Andy, Andy Groves of Intel.
Great minds think alike — like revolutionairies.
Read More & Comment...The British government has posted a “help wanted” ad for the post of director of the National Health Service in the Times of London.
I am not making this up. Check it out at http://jobs.timesonline.co.uk.
Hello Alistair Wood!
The fact that the government is willing to consider non-British candidates is (IMHO) an important sign that they’re (at least potentially) ready to look at new ways to approach the myriad of critical issues facing health care in the 21st century UK. (That’s a polite way of saying that maybe, just maybe, the Brits are beginning to admit that their system is in DEFCON 4 — not that we should brag too loudly.)
If you choose to apply, please feel free to use drugwonks.com as a reference.
I nominate Scott Gottlieb. Look British. Think Yiddish.
An incredibly clueless article on drug spending today in the AP typical of MSM coverage of Rx issues..all about prices and costs and nothing about value:
Spending on specialty drugs soar
By THERESA AGOVINO, AP Business Writer
Wed Jun 7, 12:48 AM ET
Spending on high cost specialty drugs soared 17.5 percent last year and is expected to more than double by 2009, according to a report released Wednesday.
She goes on to write:”The explosive growth is spending on specialty drugs is especially problematic because there is no pathway for generic competitors to enter the market.”
Why is this problematic? These medicines often replace halfway measures for which there are no effective treatment and are most always more cost effective than the endless surgery, hospitalization, lab tests, nursing support, home care that is required. That includes care for people with breast cancer, cystic fibrosis, Gaucher’s disease, HIV, and RA where the cost-effectiveness is well demonstrated. You did not care to cite any of this literature or experts.
Woud she be willing to hold the line on drug costs and suffer in order to make drug spending less “problematic.” Perhaps the addition of the new cervial cancer vaccine should be restricted because it to will add to “explosive growth” in drug spending.
Are reporters just that biased against drug companies or just too lazy to do more than merely regurgitate press releases or both?
Read More & Comment...The scaremongers at the NY Times are at it again with a biased piece about the use of medicines for manic depression in children:
June 6, 2006
Use of Antipsychotics by the Young Rose Fivefold
By BENEDICT CAREY
The use of potent antipsychotic drugs to treat children and adolescents for problems like aggression and mood swings increased more than fivefold from 1993 to 2002, researchers reported yesterday.
The researchers, who analyzed data from a national survey of doctors’ office visits, found that antipsychotic medications were prescribed to 1,438 per 100,000 children and adolescents in 2002, up from 275 per 100,000 in the two-year period from 1993 to 1995.
The findings augment earlier studies that have documented a sharp rise over the last decade in the prescription of psychiatric drugs for children, including antipsychotics, stimulants like Ritalin and antidepressants, whose sales have slipped only recently. But the new study is the most comprehensive to examine the increase in prescriptions for antipsychotics…
I am the father of a child who is bi-polar so my immediate response is thank goodness more parents are getting the right medication for their kids sooner then me and my ex-wife did. The years with which we and my daughter struggled with behavioral issues, depression, destructive outbursts, and other problems which I do not care to go into at this time were a direct result of misdiagnosis, mis-medication and failure to arrive at the proper combination of drugs. There is a reason the medication rates have increased: better diagnosis, earlier treatment, all of which have led to better outcomes. There is some mismanagement to be sure but with at least 1 million children with bipolar illness there is much more undertreatment. The failure of the NY Times article and Benedict Carey to even discuss the benefits of these medications and to suggest that an increase is questionable and without scientific support is reprehensible and irresponsible. This is so typical of the media who in lieu of a real story or controversy seeks to stir one up.
For real information instead of the garbage the NY Times passes off as medical reporting you can go to the website of The Juvenile Bipolar Research Foundation at
http://www.bpchildresearch.org/
The FDA said it would make Tysabri available by early June and it has done so…The risk management plan is tough but was developed in concert with patients. No thanks to the traditional MS advocacy groups some of whom had even opposed returning Tsyabri to the market. The advisory committee and the FDA officials were moved by the efforts of patients who demanded the drug’s return and by how well informed they were about risks and benefits…
Read More & Comment...Health Affairs dedicates a bunch of articles about the Oregon effort to compare drug effectiveness. We all know just how reliable and up to date literature reviews of old classes of medicines are, particularly in an era where genomics will help select medicines for patients and targeted therapies and diagnostics will shape clinical care. But let is not be said that Health Affairs is nothing by on the cutting edge of 20th century medicine. In any event, as part of it’s effort to give the underachieving access to peer review publications, it allows one Alan Heaton, head of pharmacy at the the Minn blues to weight in as follows: Give us the hard evidence for open formularies,” he demands in his Perspective. Heaton cautions that using evidence-based principles to pick superior products within drug classes risks giving the manufacturers of anointed products unwarranted pricing leverage. âIronically, pharmaceutical companies spend hundreds of millions of dollars to market product differentiation,â he observes, but âthe reality is that 80-90 percent of the population can use one drug, leaving only a small group who cannot tolerate that particular drug and need one or two other choices in a given class.”
So much brilliance here it is hard to know where to start …
Last time I checked, evidence based principles were being used to exclude drugs and select just one to drive down prices…or maybe Heaton is just a lousy businessman — as for the claim that one drug fits all — it is so scientifically without merit — SSRIs, atypicals, anticonvulsants, lipid lowering drugs, beta blockers and combination therapies thereof — that it hard to know where to begin except to extend my sympathy to the million of people who as suscribers of Minn BCBS have to suffer under Heaton’s harebrained decisions.
The other day a senior FDA official asked what the agency should do to combat all the negative media coverage. My response, “Do something because nothing isn’t working.” In retrospect that was a bit harsh. FDA has been doing things, mostly from rule-making to infrastructure, that are making a difference — albeit not any that the MSM or many elected officials seem to notice.
Two examples of moving forward towards better risk communications are the long-awaited and hugely significant new physician labeling rule and the savvy personnel choice of Paul Seligman as CDER’s new Associate Center Director for Safety Policy and Communication in the Center for Drug Evaluation and Research. Two superb examples of forward motion.
Not sexy, but crucial.
Can more be done to aggressively battle a blood-thirsty media and bandwagon pols? Don’t get me started.
Actually — do get me started.
Read More & Comment...Lots of stories today about this being the 25th anniversary of the discovery of the AIDS virus and many stories noting how many people are alive today because of protease inhibitors which the last time I checked were developed not by NIH or the Cubans or global health collaborative funded by a global R&D tax but by drug companies. The death rate in the Western world has been slashed by these drugs and the gains to society in terms of increased productvity and deferred health care costs has been substantial. Much of the recent progress has come as a result of efforts to target and personalize therapy. There are now over 60 drugs and vaccines in development. Companies have by and large come around to offer their drugs for free or at cost in those parts of the world where AIDS has hit hardest. And yet the media and activist organiizations have largely ignored this contribution. Case in point was a recent article that started out by claiming that biotech company Gilead was a war profiteer in the battle against AIDS. The last time I checked the Gilead drug was being “sold” if that term can apply for about 27 bucks a bottle ini about 100 countries compared to $800 a bottle in the US. And Doctors without Morals and other HIV activitst groups have the gall to attack Gilead for denying access. And the MSM makes THIS the lead story? Gilead has done more for those dying of HIV with its one drug that than French based group of clinical nomads has done in its decade or so of withdrawing from war torn areas and getting media coverage from Paris for its sanctimony…
Read More & Comment...Per Dr. Bob’s thoughtful blog (see below), complicated is indeed good for patients. However, “complicated” is bad for two other important constituencies — the media and policy makers. For these folks (with important exceptions) “complicated” is bad because it’s not “simple.” (Sorry, I know that sounds solipsistic, but it’s important to make the point.)
That’s why we (and that’s a collective “we” fellow drugwonks) have to work even harder to make sure those who report and those who decide report and decide based on the facts — as hard as that may be and as naive as it may sound.
The alternative is unacceptable. That’s why it’s called the Critical Path.
Read More & Comment...The media is abuzz with the news that big drug companies are rolling out drugs that will compete with cancer drugs like Herceptin that target certain pathways or genetic mutations that cause cancer instead of killing the cancer cells themselves. Not exactly. By definition, a targeted medicine does not compete since it hones in on a specific approach or response. Case in point the BMS drug dasatinib which was developed after researchers noticed that a certain subset of patients on Gleevec developed resistance to the drug after a while. Other targeted cancer drugs have the same narrow application at first but then can expand to other uses as the same pathways are implicated in other disease mechanisms…And finally, genetic and protein analysis will determine who are high responders and who are not.
It is getting quite complicated. Better for patients. Which is what matters most. The challenge will be to translate all this into solutions that reduce death and suffering and extending the model to other diseases…
Read More & Comment...DateLine NBC ran a segment tonight on counterfeit drugs. While this story is nothing new to you drugwonks out there, it’s serving as an overdue wake-up call to tens of millions of Americans. This summer, in collaboration with the Stockholm Network and the Centre for the New Europe, the Center for Medicine in the Public Interest (the home of drugwonks.com) will publish a new book called “Coincidence or Crisis: Prescription Drug Counterfeiting.” It features articles by many leading policy experts, an introduction by Congressman Mark Souder, and is edited by your’s truly.
If you would like additional information on how to order this important new book, please e-mail me at ppitts@cmpi.org.
Not coincidentally, on June 7th I will be testifying in front of the US-China Economic & Security Review Commission on the topic of prescription drug counterfeiting in China. My testimony will begin at 3:30 in room 385, Russell Senate Office Building. Transcripts of the entire hearing will be available at www.uscc.gov
Read More & Comment...Recess appointment for an important public health official.
Read More & Comment...I had the privilege to chair an FDA reform task force for the Manhattan Institute, an undertaking Mark McClellan suggested after I invited him to speak at an MI event when I was an MI senior fellow in 2003. I met with two senior FDA officals — Peter Pitts and Scott Gottlieb — that same year about how the report might help to advance the FDA’s fledgling Critical Path initiative. Peter was — like the rest of the FDAers involved in the project — visionary, supportive and courageous in combatting the negativism surrounding the effort. The Task Force we put together was (and is) dedicated, caring and thoughtful, working for free and giving graciously of their time, effort and insights. The result is a biomedical call to arms to apply the insights of drug discovery to the process of drug develpment to make medicine more predictive, preventive and personalized. The agenda surrounding the rollout of the report is below. We hope you can all attend.
AGENDA & REGISTRATION:
CENTER FOR MEDICAL PROGRESS
Prescription for Progress: The Critical Path for
Drug Development
by Robert Goldberg, PhD and Peter Pitts
M Street Hotel
1143 New Hampshire Avenue, N.W.
Washington, D.C.
Thursday, June 8, 2006
Keynote Speaker:
Andrew C. von Eschenbach, M.D.
Acting Commissioner, U.S. Food and Drug Administration
8:30-9:00 AM
Registration
9:00-9:10 AM
Introduction and Overview
Robert Goldberg, Ph.D., Chairman, 21st Century FDA Task Force, Vice President & Co-Founder, Center for Medicine in the Public Interest, Peter Pitts, Director, Center for Medicine in the Public Interest
9:10-10:15AM
Panel 1: Roundtable on Prescription for Progress: The Critical Path to Drug Development
Moderator: Michael Weber, M.D., Professor of Medicine, SUNY Downstate College of Medicine
Panelists:
Jeffrey Cossman, M.D., Chief Scientific Officer, The Critical Path Institute
Gualberto Ruano, M.D., Ph.D., President, Genomas, and Director of Cardiovascular Research, Hartford Hospital
Robert McBurney, Ph.D., Senior Vice President, Research and Development, and Chief Scientific Officer, BG Medicine, Inc,
Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs, FDA
10:15-10:30 AM
Break
10:30-11:35 AM
Panel II: The Critical Path Today and Tomorrow: Challenges and Opportunities
Moderator: Steve Usdin, Senior Editor, BioCentury Publications
Panelists:
Janet Woodcock, M.D., Deputy Commissioner for Operations, FDA
Meryl Comer, Patient Advocate for Alzheimeré¾ Research
Peter Hotez, Ph.D, M.D., Professor and Chair, Department of Microbiology, Immunology and Tropical Medicine, George Washington University Medical Center
11:35-12:15 PM
Keynote Address
Keynote: Andrew von Eschenbach, M.D., Acting Commissioner, FDA
This from Fiercehealthcare.com: ” A new study by researchers at Kaiser Permanente finds that spending caps on prescription drugs don’t save insurers money and may end up harming the health of patients—especially those who are chronically ill. The research, which appears in the New England Journal of Medicine, followed about 200,000 Kaiser Permanente patients in Northern California who had Medicare+Choice (now referred to as Medicare Advantage). The study found that those with limits were more likely to end up hospitalized and often chose not to pay for their medicines themselves. Researchers like Steve Soumerai at Harvard have essentially been saying the same thing for more than a decade now, but with Medicare in the business of paying for drugs, this type of research may have more impact on benefit design.”
So has our colleague and board member Susan Horn of the Inst. for CLinical Outcomes Research who showed way back in 1996 that formulary restrictions were associated with keeping people sicker and driving up health care costs.
On the one hand we have the WSJ editorial page claiming that there are no cost offsets to a drug benefit and on the other we have the leftists claiming that restrictive drug formularies as a tool for extracting price concessions won’t hurt patients. Yet here is another study showing that caps of any kind compromise health and drive up total spending…. And yet opponents of the drug benefit on either side keep serving up the same stupid argument in an increasingly hysterical form. How did Santayana define fanaticism: It consists of redoubling your effort when you have forgotten your aim. Exactly.
The NEJM article link can be found here:http://content.nejm.org/cgi/content/full/354/22/2349?query=TOC
And speaking of hysterical…get a load of Congresswoman Louise Slaughter’s off-base attack on Part D in the same medical journal. Compare it with the essay by Mark McClellan and Peter Bach. It’s not even worth trying to refute all the lies and inaccuracies except to say that any drug benefit that is cutting costs by massive use of generic drugs is not generating brand drug companes $139 billion in gross profits. That number, a fake factoid drawn up by the urban planner who pretends he is an economist — Alan Sager — was immediately discredited by the people who really know their stuff — the Wall Street analysts who would have issue heavy buy recommendations if gross profits would have increase 50 percent in one year….Yet the MSM and then John Kerry and now Slaughter continue to invoke this number… As it turns out of course, what drug companies that are making money are doing so with new products, many of which are not covered by Part D plans….because they are cancer products.
The two dueling articles can be found here:
http://content.nejm.org/cgi/content/full/354/22/2314?query=TOC
http://content.nejm.org/cgi/content/full/354/22/2312?query=TOC
Read More & Comment...We at drugwonks are relentless in the pursuit of more participants and wont rest until we exceed the traffic of insufferable and ego-bloated Huffington blog (amazing what how far one woman can go on her ex-husband’s money and a private jet) . But we do have a perspective…our hits are just beginning to exceed those average daily downloads of this gem: William Shatner’s rendition of Elton John’s “Rocket Man” at the 1978 Science Fiction something or other awards dinner
http://www.youtube.com/watch?v=MVbv6r_tKnE&search=Shatner%20Rocket%20Man
Cut, paste, download and enjoy and tell your friends…about drugwonks of course.
Read More & Comment...Democrat Congresswoman Rosa DeLauro is making a big stink that her amendment to have the FDA forcibly yank drugs off the market before companies are forced to conduct large randomized studies to establish a safety problem was lifted out of an appropriations bill. Rosa is hypocritical. Here’s Rosa — a cancer survivor — on the vaccine to prevent cervical cancer: âWomen across the country should be encouraged, as I am today, with mounting scientific evidence of the benefits of the HPV vaccine,â said DeLauro. âIt is clear that the science exists to fight a cancer that thousands of women fall victim to each year and there is now significant scientific and medical evidence proving the benefits of the HPV vaccine. With countless public health officials and medical providers agreeing on this medical breakthrough, I am hopeful the FDA will approve this vaccine for use.â
DeLauro, a member of that subcommittee and a cancer survivor, is also the ranking member of the House Appropriations Agriculture Subcommittee with oversight responsibilities of the FDA and its budget. In November, she and over 100 Members of Congress wrote the CDC Advisory Committee on Immunization Practices urging them to make a decision for use based on the advice of medical providers, researchers and public health officials.
As with all products, vaccines will yield safety problems in real world settings and may lead to serious illnesses and some deaths….Yet under Del Lauro’s proposal a vaccine that could wipe out 40percent of the viruses that cause cervical cancer could be yanked forcibly if companies don’t conduct safety studies that get at the source of the the problem….such studies could — because the statistical power and confidence level needed — be ten times the size of the study required to prove the product was effective. And with products As FDA official Scott Gottlieb noted in his blog (fdainsider.com),”The biggest reason why companies are unable to complete post-market studies after drugs are approved through the accelerated pathway, is that all of these drugs treat life-threatening disorders (they have to in order to qualify for accelerated approval) and dying patients are unwilling to roll the dice on a placebo controlled trial â taking a chance they may get little more than a sugar pill â when the drugs are readily available on the market.” Indeed, there are questions if it is ethical to deliberately deny a potentially effective treatment to a patient for study purposes. But Del Lauro would make it a crime not to run such trials.
In fact, there are dozens of studies being conducted independent of the FDA. For instance, Bristol Myers Squibb is working on a drug that is tailored to people whose cancer is Gleevec resistant. There are dozens of studies of genetic tests in development that if used before a drug is taken will help patients avoid well know toxicitieis.
But Del Lauro would suffocate medical progress in order to make a few headlines. She would fine the inventors of innovative medicines for life-threatening illnesses millions of dollars and would deny millions of patients accelerated access to medicines. Her amendment was a death sentence for people like her who live with cancer everyday. Is there anything people won’t do for political gain?
This will drive Drew Altman of the Kaiser Foundation nuts since he belives consumers are too stupid to decide what’s best for them when it comes to health care (has he been paying attention to the Medicare drug benefit?) it should be pointed out that in another step in helping consumers, providers, and payers make more informed healthcare decisions, CMS will be posting information on what Medicare pays for 30 elective inpatient hospital procedures and other common hospital admissions later today. The new information will be posted by CMS at www.cms.hhs.gov. The information takes a snapshot look down to the county level at the amounts paid by Medicare paid for a variety of treatments provided to seniors and people with disabilities in fiscal year 2005. These include procedures such as heart operations and implanting cardiac defibrillators, hip and knee replacements, kidney and urinary tract operations, gallbladder operations and back and neck operations, and common non-surgical admissions.
The information is scheduled to be posted around 2 pm today. A press release will announce the posting of this information.
RE: Follow-on Biologics
Beware putting cart before horse.
And don’t call them generics.
“Indeed, wretched the man whose fame makes his misfortunes famous.”
— Lucius Accius
Bloomberg reports that, according to a sealed transcript of videotaped testimony taken for Vioxx litigation, Dr. David Graham accused FDA officials of working “hand in glove” with Merck to tarnish him.
Are you thinking “visions of grandeur?” Keep reading …
“I experienced threats, intimidation and actually what, in my view, appears to have been a very organized and orchestrated campaign to smear and discredit me,’” said Graham.
Here’s the threat — an important new job.
Graham said former FDA Commissioner Lester Crawford had offered him a promotion nine days before his Senate testimony. Graham said he declined and was surprised by the timing.
“The commissioner is offering me this really high-level job with a lot of responsibility, and then one week later, he’s calling me all sorts of names in an FDA public statement that’s issued on the eve of my Senate testimony,’” Graham said.
Really? I don’t recall any name-calling by Dr. Crawford. And why didn’t Graham accept this “really high level job with a lot of responsibility?”
Why not work to make things better?
Odd? Mysterious? Nope. Just sad.
David, your 15 minutes are up.
Read More & Comment...Many Canadian Internet pharmacies are quite open about the fact that they’re getting their southern-bound drug supply from the UK. No problem there, right? Na-ah.
The Royal Pharmaceutical Society of Great Britain (RBSGB) and the Medicines and Healthcare products Regulatory Agency (MHRA) have collaborated on new guidance for pharmacists which explains the causes and consequences of counterfeiting and provides pharmacists with practical advice on detecting and reporting suspected counterfeit medicines.
The guidance has been jointly developed by the Royal Pharmaceutical Society of Great Britain and the Medicines and Healthcare products Regulatory Agency following a meeting of the Society’s Practice Committee where the dangers of counterfeit medicines were debated.
Guidance for pharmacists explains the background to counterfeit medicine production and highlights how organised criminal gangs have become involved in the production of illegal medicines and are supplying them through the internet, often to unwitting patients. The guidance offers pharmacists invaluable practical advice on the correct steps to take when they encounter suspected counterfeit medicines. These steps include reporting the situation to the MHRA and ensuring immediate patient safety.
David Pruce, director of Practice and Quality at the RPSGB said, “Counterfeit medicines can be extremely dangerous. They may contain little or no active medicine, a totally different medicine or a toxic chemical. The RPSGB has teamed up with the MHRA to provide invaluable guidance for pharmacists, particularly on how to report instances of counterfeit medicine supply to the MHRA.”
Read More & Comment...
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