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His video interview can be found here:
www.vimeo.com/1045899
(Other "newsmakers" interviews can be found at www.cmpi.org)
Dr. Weber, we are proud to say, serves as Chairman of the Board for the Center for Medicine in the Public Interest (the public policy home of www.drugwonks.com).
Read More & Comment...
According to Bloomberg, two companies that produce different types of stem cells have signed contacts to sell their products to drugmakers, showing the new technology will be used to help discover medicines not just to repair or replace damaged cells.
California Stem Cells Inc., an Irvine, California, biotechnology company that turns embryonic stem cells into neurons, said today it's selling the brain cells to researchers trying to find drugs to treat Lou Gehrig's disease. CellDesign Inc., of
The efforts of these two closely held companies indicate stem cells will aid in the search for old-fashioned drugs long before they're infused into patients. It also suggests that the first businesses to benefit from stem cell technology will be traditional pharmaceutical companies and their suppliers not developers of new kinds of therapies.
``It's similar to what happened in the last century with molecular biology'' and gene therapy, said John Hambor, CellDesign's founding chief executive officer, in a telephone interview yesterday. ``We're now going down a similar path with stem cell biology. While it may lead to cures by itself, it will drive the next generation of drug discovery.''
Here's a link to the complete story:
http://www.bloomberg.com/apps/news?pid=20601124&sid=aYKfThhsUVwI&refer=home
At a recent European Commission-sponsored high level conference, Internal Market Commissioner Charlie McCreevy, commented that the EC wants practical, pragmatic suggestions for fighting the “modern-day highway robbery” known as piracy and counterfeiting. McCreevy stressed that more regulation is not the answer, and that solutions lie with public-private cooperation.
Only governments can put into place enhanced investigatory assets and harsher penalties.
Public/Private cooperation? Certainly. But only governments can catch and keep criminals in jail.
When it comes to discouraging international prescription drug counterfeiting, what we need is a more robust cell culture.
Now it turns out that Avastin, the drug that Goozner and Mahar love to hate shows considerable promise in extending average progression free survival by up to nine months. Contrary to the twisted narrative put forth by critics, the discovery of the off-label use of Avastin for gliomas came from academia without industry funding (which of course Goozner also criticizes...either way industry is damned, pilloried for inventing useless new uses and attacked for not being innovative)
Here's what happened:
"In the pilot study, the researchers found that dual therapy with Avastin and the chemotherapy drug irinotecan either shrank the tumors or restricted their growth in nearly all cases for up to three months longer than comparative therapies. Three months is a significant advance when dealing with these aggressive tumors, Vredenburgh said; common current treatment normally offers only six to 12 weeks of halted growth before the tumor grows and spreads, ultimately destroying cognitive and physical function and leading to death."
Following this discovery, Genentech, Duke University and NIH worked together to conduct an expanded study.. The FDA initially resisted because of side effects such as bleeding, but since 40 percent of all brain cancer patients experience bleeding for a fatal illness the risk seemed worth it (to everyone except Maggie Mahar www.healthbeatblog.org/2008/02/the-wall-street.html
James Vredenburgh, M.D., a brain cancer specialist at Duke's Preston Robert Tisch Brain Tumor Center and lead researcher on the study noted: "Going forward, we will also explore the efficacy of this treatment in newly diagnosed patients," he said. "Ultimately, our hope is that this will offer a real weapon in what is now a very limited arsenal for treating a very challenging cancer."
www.cancer.duke.edu/btc/modules/news/article.php
That includes patients like Senator Kennedy. Let's hope that his doctors rely upon experts like Vredenburgh in making treatment decisions, not cynical second guessers like Goozner and Mahar who would let hatred of drug companies color life and death decisions. Read More & Comment...
Ford and From describe the Center this way:
"The American Center for Cures would be a public/private partnership that would function as an independent entity within the National Institutes of Health, targeting research resources from government, academia and the private sector on cure-driven projects. It would pay for high-risk, high-reward research, fund small businesses that have created possible cures but lack the money necessary to test drugs in clinical trials, and work to streamline the clinical trial process."
There is a danger is politicizing science of course, (what else is new?) but if the ACC can roust the NIH out of its current torpor and shift resources towards more partnerships and clinical trial reform, it is worth a discussion.
thomas.loc.gov/cgi-bin/query/F
Read More & Comment...
Biotechnology companies also raised $29.9 billion in investments and loans, the most since 2000. The industry attracted a record $39.4 billion in 2000, the year the first draft sequence of the human genome appeared.
IPOs brought in $2.2 billion, a 21 percent increase over the previous year and the highest total since 2000.
The full Bloomberg story can be found here:
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a6FjDvLrCCgM
The article mentions that, “Large drugmakers are investing in biotechnology to gain new medicines to bolster revenue as patents on top products expire.”
No doubt. But while acquisitions and licensing is the wave of the present, what will drive the future of pipeline, profit … and public health is the Critical Path. To achieve “A” level health care, industry and academia and government must focus on “B” level issues -- Better science and better tools (biomarkers, bioinformatics, and Bayesian statistical analysis) among others.
So, deal or no deal, the Critical Path must not remain the road less traveled.
Read Boston Globe article
I have noted previously that other friends of mine have received combination of Rituxan and Avastin to treat NHL. (Other drugs for NHL such as Bexxar will hopefully grow in use as treatments are tailored to individual disease progression.) Both of those drugs were not and are not widely available in single payer health systems. Cynics like Merrill Goozner even believe Avastin is worthless. My advice as always is for people to receive medical care consistent with their ideological position and refuse medicines they believe were brought to market or marketed in ways that are corrupting or without the evidence they believe meets their utopian formulary. And don't let your family have access to the same drugs either.
Leave Jon Lester and the rest of us alone. Read More & Comment...
"A drug company brings a new drug to market based on government-funded research. It charges a huge price for the drug, but since its the insurance companies money, it's everyone's money, which means it's no one's money. So no one complains -- for a while. What does Teva do with the huge cash flow that comes from selling this very expensive drug to a small population of MS sufferers? It funds clinical trials to show it's drug is superior to other in the field, which it shows, sort of. But the trials are never really good enough to prove superiority, just good enough to establish market dominance, which was probably the real goal of the trials. So the government has to sort things out, but it gets back into the game very late and very slowly. The insurance industry, fed up with paying extraordinarily high prices, starts putting the financial onus on patients."
www.gooznews.com/archives/cat_drugs.html
Goozner is referring to the Tier 4 payment category which by itself is crazy. But all of a sudden comparative clinical trials are no good. Maybe they should be bigger and government run. Then there would be no drugs except the one drug selected by government to hit the market. But wouldn't that create a monopoly price? No problem. In the Gooz's world. The price would be slashed by licensing out product to generic companies who would sell the rights to produce the breakthrough at pennies per dose.
Because innovation all flows from government anyways and all the R and D and the marketing and education carried out by private companies is sort of just greedy rent-seeking behavior of the basest sort... I would have no problem have a respectful debate on the best way to advance medical progress but Goozner and others want to shut off debate by attacking motives and funding sources. As I have noted, it cuts both ways but the media and the blogging world are intensely hypocritical on that score.
One other Goozworthy note...He claims I don't support embyronic stem cell research. He infers that because he asserts I am a conservative and CMPI is conservative and therefore assumes I hold down the line social conservative positions. In otherwords, Goozner who never bothered to check or ask me. For the record, I support ESC research though I have tremendous respect for the positions of those that do not and I don't write about it because it is not an area that is CMPI's central focus. Read More & Comment...
Doctors' protests are symptoms of a sick society
By Jacob Arfwedson
Corralling doctors has been an objective of French health policy for more than 20 years, with restricted entry to medical schools and financial incentives for early retirement.
The justification for such coercive guidelines around
Restricting access to doctors or treatments frequently results in costly invasive surgery, and/or longer hospital stays. Good healthcare inevitably means people live longer, which inevitably increases costs. But is the unspoken position of finance ministries that they would prefer citizens not to live so long?
Doctors and patients are increasingly weary of government-imposed healthcare management systems that lead to waiting lists and one-size-fits-all treatments. Many seek care abroad:
People value time and attention from doctors. In
Wrong-headed government attacks on standards are provoking protest among a profession with little natural inclination for going onto the streets. In
Two-thirds of German doctors resent the interference that limits them to a maximum of ten minutes for most patients and that penalises them for prescribing expensive drugs. More than half the German public reckon they are no longer getting the optimum treatment from their doctors.
Doctors’ protests are symptoms of a sick system. Healthcare should be viewed not as a burden but as an investment. Market-based provision and financing is the only way to turn healthcare into the growth industry it should be.
Doctors have yet to make their voices heard in the battle of ideas between the guardians of socialised medicine and proponents of a free healthcare market. The outcome will shape the fate of their patients and their own profession. They can ill afford to ignore the debate.
Jacob Arfwedson is director of the Centre for Medicine in the Public Interest in
Read More & Comment...
To that end, CMPI (the public policy home of drugwonks.com) is pleased to offer a new omnibus overview of what the EU refers to as "Information to Patients" (ItP) -- "Who wants to know?"
"Who wants to know" is written by CMPI senior fellow Jacob Arfwedson. He's the chief of our Paris bureau. A Swede who speaks French and German and writes in English.
And he's controversial in any (and every) language.
To access "Who wants to know," go to www.cmpi.org and look under "research papers."
Read More & Comment...
"In theory," because the meeting did address this issue -- but the majority of the time was spent discussing other things.
First up was supposed to be Kit Aikin to present the FDA's proposed study protocol -- but she was feeling under the weather and was replaced by the very capable (and very pregnant) Amy O'Donoghue.
Amy discussed the FDA's proposed research experiment (sampling, design, proposed stimuli, etc.) and the always fascinating Federal Paperwork Reduction Act. The latter because she needed to remind the committee about our fourth branch of government -- the Office of Management and Budget -- and how OMB regulations impact the general timing of the FDA rule-making process.
(When asked how long it could take to complete the rule making process, Kristin Davis of DDMAC commented, "You're looking at a couple of years." And this is after the 24 months the FDA has to complete the research study. One committee member was incensed and commented that Congress' intent was probably to delay the issue indefinitely and that something should be done about this OMB thing.)
BTW -- all the presentations, including the research protocol slides, can be found at www.regulations.gov. (reference docket FDA-2008-N-0226).
Some of the issues that came up:
* The use of the terms "adverse event" and "side effect" being used inter-changeably. Just what do consumers think they mean? The committee seemed to think that the FDA should look into this.
* How can poly-pharmacy patients report an adverse event when they can't be sure what's caused it?
* Will an 800 number (presented via a super, audio, or both) cause a "power of suggestion" situation, thus producing a kind of adverse event "placebo effect."
These general themes led the committee to worry (and rightfully so) that information reported via an 800 number would likely provide the FDA with data of questionable quality and utility. A serious "signal-to-noise" issue. Of particular worry was how the FDA would then use this information relative to communicating "early safety signals." Talk about unintended consequences!
* Speaking of FDA's use of information, it came out that DDMAC isn't looking at MEDWATCH reporting data. Explantation: they don't have the staff time to do the extra work. Bad excuse. Seemed to me, based on the response of the agency folks present, that this isn't something DDMAC's ever even thought about.
* Per how to best present an 800 number, there was general committee consensus that it would require both a super as well as audio. The "super-only" concept was shot down by one panelist who commented that "people aren't going to have pens and paper at the ready to copy down a number."
(Note to pharma physician detailers -- maybe a new use for pens.)
One committee member even suggested a "CNN-like crawl" that might run continuously during TV ads. (So now we're going to make risk information less distracting by making DTC ads more distracting?)
* Much discussion as well on how a regularly communicated 800 number would advance "the FDA brand" -- by showing that the agency is taking the lead not only in drug safety, but in safe use of medicines. Committee Chair Fischhoff commented that "the better the FDA brand, the better the industry brand."
Amen.
The concept of an FDA public service announcement on reporting adverse events/side effects was discussed at great length -- as well as how the agency might pay for production and get media placement. And there were a lot of "creative" ideas about the PSA. At this point, lots of people in the audience began picking at their blackberries.
* Much time also spent discussing the need to educate the American public that all drugs have both risks as well as benefits.
Where have I heard that before?
Here's the brief Reuters report of Day Two:
www.reuters.com/article/healthNews/idUSN1641693720080516
My favorite comment came from a note handed to me during the meeting that said, "Hmm, a 1-800 number for ED ads? I thought those would be 1-900 lines and cost $3.99 a minute."
As always -- where some see a problem others see opportunity. Read More & Comment...
vimeo.com/1020779
Speaking to an FDA advisory committee is one thing, speaking to the American public --the ultimate advisory committee -- is something else entirely.
(And the latter is more intimidating.)
Read More & Comment...
Solid presentations from all my old buddies -- Ellen Frank (Director of Public Affairs/CDER), Mary Hitch (Senior Policy Advisor, Office of the Commissioner), Cathy McDermott (Director, Public Affairs, ORA) and Karen Feibus (OND, CDER).
They all presented their terrific work. All the more so considering the shoe-string budgets under which they operate.
But what does any of this have to do with DTC and under-served communities?
Let's just say it's tangential.
But (and not surprisingly) it really caught the attention of the committee. Good conversations, lots of kudos, some good ideas about how the FDA could do a better job in leading the "safe use" conversation ... but at the end of the day, and as interesting and important as it is ... it's mission creep.
Danger, Will Robinson, danger.
Day One closed with "Committee Discussion." Some nutty. Some really useful.
Some examples:
* A lot of comments on how FDA could do a better job on it's own communications efforts and a general call for the agency to get/allot more money for FDA communications efforts.
* The need for the agency to create an "Office of Minority Health"similar to the FDA's existing Office of Women's Health (often referred to as the "WFDA"). Good idea.
* A "Critical Path" program for health care communications/health literacy that would include the FDA, academia, other government entities (i.e., the FTC) and industry.
Yes, industry.
A potential hornet's nest for all the obvious reasons (hello Representative DeLauro), but a nifty idea.
* And some really wacko comments such as that the FDA should pre-review television ads "after they have been produced." And my other favorite, that DDMAC should pre-review "media placements."
At the end of the day, the issue the committee was supposed to address -- how DTC impacts under-served communities (socio-economic, minority, elderly) was answered in three simple words ... not enough information.
Onwards to Day Two and a stimulating conversation on 800 numbers for television ads.
Read More & Comment...
In closing, I urged the committee to ponder this question posed by T.S. Eliot:
"Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in Information?
Is anybody listening? Read More & Comment...
Conclusion -- there isn't a lot of it and the studies that exist are "scattered and preliminary."
The recommendations of the committee -- more research.
Very helpful.
This hearing is beginning to be like treading water in treacle. Read More & Comment...
Committee chair Baruch Fischoff seemed somewhat perplexed at the general lack of industry comment (although he did specifically mention the importance of the docket). He then said a rather disturbing thing -- that industry should attend the meetings of the committee so they could "learn something that can help them make a buck."
I hope that someone at the FDA's Office of Advisory Committee Oversight reminds Dr. Fischoff of his role and the importance of choosing his words more carefully in the future.
Read More & Comment...
According to the publisher (Wolters Kluwer Health), The Patient is "an invaluable source of applied pharmacoeconomic original research and educational material for the healthcare decision maker. The journal is dedicated to the clear communication of complex pharmacoeconomic issues related to patient care and drug utilization."
Here's a link to the magazine's website
John Bridges (Johns Hopkins School of Public Health and Senior Fellow, Center for Medicine in the Public Interest) is the journal's lead editor.
(And, in the interest of full disclosure, I am on the editorial board.)
Here is a link to the magazine's website: http://thepatient.adisonline.com
We welcome this important new voice to the debate.
Read More & Comment...
washingtontimes.com/apps/pbcs.dll/article Read More & Comment...
For example: The bill would "establish a code of ethics for the practice of pharmaceutical detailing and collect information from registered pharmaceutical detailers relating to their communication with health care professionals, health care providers, or employees, agents or representatives of health care professionals or health care providers located in the state.”
What about the existing, rather stringent, government and industry regulations? Is the state going to legislate a floor or a ceiling? And as far as “collecting information,” that’s a pretty strong dose of Big Brother if you ask me and begs the question, “Whose next?”
The bill states that, “A pharmaceutical detailer shall not: engage in any deceptive or misleading marketing of a pharmaceutical product … For purposes of this section, it shall be considered an act of deceptive or misleading marketing to provide information regarding a use of a pharmaceutical product not approved by the federal food and drug administration.”
Even though the actual verbiage makes it sound as if pharmaceutical detailers shouldn’t be promoting investigational drugs (no argument there), I’m sure what Mr. Gottfried meant to address is off-label promotion. Perhaps he should have a chat with the folks at the FDA to, um, seek “guidance” on the matter. Or at least he should consult with an attorney familiar with the various and un-subtle legal precedents. (And what about the fact the FDA already regulates all educational efforts between physicians and sales reps? Inconvenient truths.)
Moving from the uninformed to the subjective, the bill states that all pharmaceutical detailers must, “be of good moral character and suitability.” According to whose standards? Elliot Spitzer?Quis custodiet ipsos custodes?
In the “Justification” section, the rational for this legislation states that, “Pharmaceutical companies are increasingly using detailers to go into doctors offices and market their prescription medicines.” But the fact is, for accuracy’s sake, that pharmaceutical detail forces are on the decline. Oops.
But what are facts when you have a research study done by that unbiased arbiter of truth and justice – Public Citizen. In discussing the need for a state-mandated code of ethics, the “Justification” continues, “A 2005 study conducted by Public Citizen and published in The Journal of Public Health Policy found that more than half of the drug makers participating in the 2002 America Psychiatric Association convention violated either the Association's own drug marketing guidelines or FDA rules.”
Further, “Congressman Henry Waxman of the House Committee on Government Reform found that "there has been a marked decline in enforcement actions taken against drug manufacturers by the FDA for illegally promoting their products since December 2001.” Perhaps a conversation with the FDA might enlighten Mr. Gottfried and his co-sponsors to the reality of the situation. (And a primer on federal preemption would also probably be useful.)
If this whole thing sounds familiar – that’s because it is. Remember the District of Columbia “Safe Rx Act of 2007? The devil is in the details – not the detailers. Read More & Comment...
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