Latest Drugwonks' Blog
This will make the pharmaceutical purists and conflict of interest capos sick am I sure. There is now nowhere in the world where their views have been turned into policy or law...except North Korea or Cuba. Here's the post from Fastercures Smartbrief...
EC wants more research headed to product development
The European Commission is asking for more interaction between universities and pharmaceutical companies to ensure that research knowledge is more quickly translated into products and services. The EC adopted a recommendation on how member states can revise their policies to allow public research organizations to leverage intellectual property more effectively. In-PharmaTechnologist.com
content.nejm.org/cgi/content/full/358/17/1774
“Drugmakers haven't made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators. The Food and Drug Administration determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun, according to the FDA.”
Here's a link to the complete story:
www.bloomberg.com/apps/news
Yes, I know, it’s not that simple – but that being said, it’s true. And that has to change. While this issue does play into the hands of the usual suspect safety jihadists (note quote in article by Peter Lurie) – promised studies should be commenced promptly.
Yes, there are many relevant and extenuating circumstances (note quote from PhRMA), but, as far as industry is concerned, this is a self-inflicted wound that spin cannot fix.
Have a look at this new article (from the Journal of Life Sciences) on how the EU is pondering changing what's allowable vis-a-vis what they call "Information to Patients" and we in the US call "Direct to Consumer Communications:
www.tjols.com/article-640.html
Bottom line -- knowledge is power.
According to Andy Pollack's story in today's New York Times:
"Proponents say the new law, more than a dozen years in the making, would help usher in an age of genetic medicine, in which DNA tests might help predict if a person is at risk of a disease, allowing action to be taken to prevent it.
Some of the tests already exist, like one for breast cancer risk, and new ones are being introduced almost every month. But backers of the legislation say many people are afraid of taking such tests because they fear the results would be used to deny them employment or health insurance.
“This bill removes a significant obstacle to the advancement of personalized medicine,” said Edward Abrahams, the executive director of the Personalized Medicine Coalition. His group is an organization of drug and diagnostic companies, academic institutions and patient groups that advocate using genetic information to choose the most appropriate treatment for each patient."
Here's the rest of the story:
www.nytimes.com/2008/04/23/business/23gene.html
All sounds good, right? Hopefully.
We'll wait and see, when the payer is the government , if Uncle Sam retains the same "keep your hands outta my genes" philosophy.
But, in the meantime, well done.
"Last year, this nation's regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people," said Rep. Bart Stupak, D-Mich. "If we don't make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us."
That's rich coming from a guy who helped push up the suicide rates by scaring parents away from antidepressants. and who is pushing for drug importation at a time when Al Qaeda and Hezbollah are involved in drug counterfeiting....Andy must have to shower after sitting through such a show trial...
www.fraudaid.com/scamspeak/conprods.htm
Meanwhile the Steve Nissen fear factory spews out another piece of tabloid medicine: EKG monitoring of all kids getting stimulants for ADHD.. Now there's a way to achieve Nissen (who has never studied ADHD) goal of making a physician's hand quiver before writing a scrip for the drug....But will it improve prescribing? Ron Winslow of the WSJ nails it:
"Since 1999, fewer than 30 sudden deaths among children have been linked to the drugs, which are currently taken by more than 2.5 million youngsters in the U.S. Issues of cost, available expertise in reading children's ECGs and concern about false-positive tests are prompting some experts to question the rationale for urging an ECG in particular.
"This is a $250 million recommendation," says Mike Ackerman, a pediatric cardiologist at the Mayo Clinic in Rochester, Minn., who estimates the total cost of an ECG at about $100. "We're really trying to find a needle in a haystack, and we have no data yet to know that the screening program they're recommending would capture" those few at-risk individuals. Dr. Ackerman was a member of another American Heart Association panel that last year stopped short of recommending routine ECG screening for heart abnormalities in young competitive athletes."
Read the Wall Street Journal article
FInally a pattern appears to emerging that has escaped even the great John Wennberg: the life expectancy of poor people is declining even as that of others is increasing. Women in particular are dying earlier than men in rural areas. Can we say Medicaid and SCHIP anyone? And I should note that Frank Lichtenberg spotted a decline in life expectancy among the elderly in the VA, the same VA that Shannon Brownlee -- Wennberg's Boswell -- is pushing as the example of what we all should be forced into in the Dartmouth comparative effectiveness utopia. Eeech...
Here's the article by the ever wonderful Maggie Fox of Reuters with a link to the study which is pretty methodologically sound:
www.reuters.com/article/scienceNews/idUSN2146521720080422
www.nypost.com/seven/04202008/postopinion/postopbooks/foul_shots_107320.htm
Important article in today's Wall Street Journal on OMB's Peter Orszag.
Here's how it begins ...
As the presidential candidates and Congress rev up the debate over the future of health care, Peter Orszag is already playing one of the toughest positions: referee.
Mr. Orszag, a 39-year-old economist, is the director of the Congressional Budget Office, the influential agency charged with toting up congressional bills' impact on the federal budget. Such scoring can sink bills that can't offset their costs with savings -- a serious risk for proposals that aim to expand federal health programs to cover more citizens.
Mr. Orszag increasingly is focusing on health issues, taking an unusually high profile for his nonpartisan office. He has become a prominent speaker at health conferences and co-wrote two pieces in the New England Journal of Medicine. He has launched a blog, cboblog.cbo.gov/, boosted the number of staffers who work on health to 47 from 31 and is seeking to add more. The agency has 235 employees.
"This actually is our fiscal future, and policymakers do not have as much analysis and options as they would need to make sound long-term decisions," says Mr. Orszag.
Here’s a link to the complete article:
http://online.wsj.com/article/SB120874132955630171.html?mod=hps_us_inside_today
The CBO's health-care work "will be very instructive to members when we attempt to take steps to right the ship," says Sen. Kent Conrad, the North Dakota Democrat who chairs the Senate Budget Committee.
Indeed – but let’s also add to the equation short-term versus long-term issues. And as obvious as that sounds, long-term often gets glossed over – particularly during a national election cycle – when "tough problems" (like safety and cost and rationing of care) don’t necessarily support more populist sound-bites like “importation” and “universal coverage.”
Over a year ago the Wall Street Journal published a piece “exposing” that some medical journal articles are – gasp – drafted by professional medical writers and then edited (often heavily so) by the bylined authors before they are published!
The New York Times must have missed it, because on Saturday the New York Times ran a very similar article. All the news that’s fit to print?
Here’s how Stephanie Saul began her article, “The pharmaceutical industry glimpsed its own ghost this week, and the apparition could not have arrived at a worse time for drug makers.”
Cute. Here’s a link to the complete article:
www.nytimes.com/2008/04/19/business/19ghost.html
The real question on the table is whether it’s right and appropriate for pharmaceutical companies to be involved in the drafting of medical journal articles that are based on their own studies of their own products. Hullo? Okay, let’s try this – how about, is it right and appropriate for pharmaceutical companies to blur the line between marketing and science? That’s a better question, but it presupposes that all marketing is bad and all science is good.
Let’s pursue that proposition. Who would think marketing and science make poor bedfellows? Well, cui bono? Surprise! The people at the front of the anti-marketing, pro-science queue are the editors of our medical journals. After all, if these self-appointed Sultans of Science cease to be the singular gatekeepers of new scientific information then, quite logically, the world will come to an end. The canard that ghostwritten articles in any way denigrate the nature of the material is such a transparent and disingenuous attempt on the part of medical journal editors to discredit the pharmaceutical industry that it is (or should be) embarrassing. It brings into real question the better (Marcia) angels of their nature.
Other folks with an agenda here (and who are portrayed in the New York Times story as “advocates”) are those who have a vested interest in not having more expensive drugs available for patient care – aka payers. And, of course, there’s the mandatory quote from Sid Wolfe.
Next time you read an op-ed in your favorite newspaper by a well-known personage consider if a ghostwriter was employed. Answer: Probably. Next time you hear your favorite politician give an address ask yourself if the speaker wrote the speech. Answer: Probably not. And then ask yourself this – does it make a difference? If the article or the address truly represents the beliefs of the “byline,” then it’s like that TV commercial, “We don’t make a lot of the things you use. We make a lot of the things you use better.”
Me, personally, I’d rather read articles that are well written. I also believe that if the incursion of professional writing assistance makes the articles better, then that’s a good thing because it tends to make dense data more easily understandable.
When it comes to healthcare everyone, it seems, wants to talk about patents.
Congress wants to reform them.
The WHO wants to circumvent them.
Some, such as Bernie Sanders (the Senator from Ben & Jerry's) want to eliminate them.
All concerned address the issue with passion and an interest in improving global public health.
But, even with the best intentions, they're missing the point. We need to focus beyond reforming patent law. We need to rethink the existing system to encourage pharmaceutical innovation (both incremental and discontinuous) in order to realize the potential of the Biomedical Century.
And not just in the US -- but globally.
The solution isn't exclsively patent reform -- that's too narrow. We need to consider new strategies that enhance and protect intellectual property rights. What we need to seriously study -- and transnationally -- is the issue of data exclusivity.
There are some numbers that are too important to ignore. Today it takes about 10,000 new molocules to produce 1 FDA-approved medicine. And if that's not frightening enough, only 3 out of 10 new medicines earn back their research and development costs. And here's the kicker -- unlike other R&D-intensive industries, pharmaceutical investments generally must be sustained for over two decades before the few that make it can generate any profit.
Current patent life just doesn't cut it. Not in the US. Not in the EU. And certainly not via TRIPS.
If we don't think seriously about moving away from patent reform and towards more robust protection of data exclusivity we are going to seriously jeopardize the potential for new medicines -- at a time when science makes potential breakthroughs tantalizingly close.
Do we really want promising compounds abandoned because of awkwardly crafted and inconsistent (read "unpredictable") patent terms?
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.
