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Many attendees support a proposal to replace drug patents with a “prize” system, wherein governments offer monetary rewards for new pharmaceuticals. A central WHO bureaucracy would decide which diseases are worth researching, establish prizes accordingly and then put the formulas into the public domain, allowing anyone to produce generics.
What could justify this overhaul? Proponents argue that patents keep drug prices artificially high and that pharmaceutical firms spend too much money on “lifestyle” drugs aimed at Westerners and too little on treatments for developing-world diseases.
Have a look at this article for further discussion of this foolishness:
www.metro.us/metro/blog/my_view/entry/Theres_a_prize_in_every_box/12382.html
The patent system doesn’t cause firms to ignore the developing world. Roughly half the research projects into Third World diseases are run by drug companies. The claim that prices keep drugs from poor patients is equally untrue. The reality? Developing countries lack the infrastructure for drug distribution. As the WHO’s HIV division director put it in 2006: “It is very obvious that the elephant in the room is not the current price of drugs. The real obstacle is the fragility of the health systems. You have health infrastructure that is dilapidated, and supply chains that don’t exist.”
Prizes might work in industries defined by “eureka” achievements like space travel. But drugs come from a long, incremental process of testing and retesting. Prizes only reward breakthroughs, not intermediate steps. Replacing pharmaceutical patents with a prize system would do untold damage to millions of poor patients.
Read More & Comment...
One effect of comparative effectiveness: it locks in racial disparities in the treatment of chronic illnesses that lead to higher rates of death among African-Americans. Cost containment is achieved by letting minorities die more often.
Gene Variant Protects Black Heart Failure Patients
MONDAY, April 21 (HealthDay News) — Researchers have discovered a gene variant carried by about 40 percent of blacks that protects them after heart failure as much as widely used beta blocker drugs do.
The finding explains the puzzling results reported in trials of beta blocker therapy in black people, said Dr. Stephen B. Liggett, a professor of medicine and physiology at the University of Maryland, and co-author of a report in the April 20 online issue of Nature Medicine.
"To our knowledge, this is the first case where a genetic variant mimics the activity of a drug used to treat a disease," Liggett said.
The finding won't have an immediate effect on treatment of heart failure, the progressive loss of ability to pump blood that affects an estimated 5 million Americans, said study co-author Dr. Gerald W. Dorn II, director of the Center for Pharmacogenomics at Washington University in St. Louis. Doctors can continue to prescribe beta blockers for people with heart failure, black or white, since the drugs have little risk, he said.
But there should be an effect on future medical practice, Dorn said. "One idea in the future of drug discovery is that we will not only need to tailor therapy for individual genetic makeup but also take genetic makeup into consideration in drug testing," he explained.
Comparative effectiveness is completely ignoring such advances and the life saving benefits they bring. Remember Nitromed?
In this case people with the variant might not need a beta-blocker or as high dose. Those without will need it, Still other variations might lead to developing other regimens.
Liggett noted: “Our idea is not to replace the physician's judgment, but to give a handle on which drugs they might want to push to higher levels and which are less likely to be helpful for specific individuals.”
Unlike population-based comparative effectiveness which ignores individual differences that – for African Americans suffering from diabetes, hypertension and breast cancer – could mean life and death.
Which is why comparative effectiveness is just Jim Crow medicine unless it’s put on a personalized path.
Doug Holz Eakin, John McCain's policy chief and Carly Fiorina, McCain campaign chair ran a conference call for the media on McCain's emerging health care vision. In essence it is this: give people money to buy coverage and seek out care anywhere that prevents disease and rewards providers and insurers that do the best job treating illnesses. Instead of an insurance system that profits from finding ways not to cover people, McCain would find ways to get insurers to compete to treat people in high quality settings and get rewarded accordingly. Consumers would have information and dollars to seek out service in this new market. How about that? Sick people being sought after by insurance companies -- much like hungry people are sought after by restaurants and grocery stores.
This is an emerging and provocative vision. More to come...
Don’t Compromise the Safety of Biotech Drugs
By Bryan A. Liang
The comparison is worth keeping in mind as the debate heats up over "follow-on" biologics. Biologics are today's most advanced medicines, fully tested biotechnology protein drugs that provide targeted therapy to victims of cancer and other diseases. Follow-on biologics are the second or subsequent versions, but they are not identical.
Congressional legislation is pending that would allow the sale of follow-on biologics without requiring extensive testing -- essentially following the same model used for approval of generic forms of traditional prescription drugs.
But most drugs we're familiar with, like the pills we get from the pharmacy, are "small-molecule" drugs -- simple chemical compounds. They can be easily manufactured and identically copied. The anti-convulsant drug valproic acid, for example, has a total of just 26 atoms.
Identical to the brand-name version, these generics can "piggyback" on a brand-name company's testing. That's reasonable. These small-molecule drugs -- which typically are made up of a total of 20 to 100 atoms -- can be copied perfectly. So they don't need independent safety testing, cost less to make and are cheaper -- allowing more patients to obtain the medical benefits.
But biologics are far more complex. The brand-name drug Herceptin, a biologic that's widely used to treat cancer, is made up of a total of roughly 25,000 atoms. Large biologics can have millions of atoms.
Biologics aren't made by combining chemicals in a flask. They're made by life forms such as cells, yeast and bacteria. Like humans, these life forms exhibit diversity in metabolism and composition, making the final product a unique, heterogeneous mix that cannot be copied exactly. So follow-on biologic forms of a drug can only be similar to the original, not identical.
Because of the complexity of biologics, there's more regulation. In comparison with common chemical drugs that can have generic versions -- such as penicillin -- which only require 50 to 60 manufacturing tests for safety and quality, biologics require at least four times that number.
So the policy challenge is to provide incentives for innovation while also ensuring that any follow-on forms of biologics that enter the market are safe.
The key lies in something called "data exclusivity," which is a legal mechanism for allowing a company to keep confidential the data associated with a drug's development. Data exclusivity usually lasts for several years and spurs innovation by protecting new inventions. This is the current rule for small-molecule drugs, and it should be applied to biologics as well. Strong data exclusivity is critical for biologics, which are about 50% more expensive to develop than small-molecule medicines.
However, the current state of science makes ensuring safety of follow-on biologics difficult. Currently, the technology to map out the exact chemical structure and function of one large biologic versus another is not available. That makes safety reviews inexact. And follow-on forms may induce unpredictable adverse reactions.
Several years ago, a fully tested biologic created in the
If even cooperative company efforts can result in unpredictable adverse reactions, any follow-on product that does not undergo full testing should be of concern. Recognizing this reality, the European Union has developed a system of assessment that requires clinical testing of follow-on products in
If chemical drugs were toy planes, biologics would be 747s, the cutting edge of medicine. Because of their complexity, any follow-on forms must be held to a higher safety standard. As we have learned in aviation, safety is no accident.
Bryan A. Liang is executive director of the
From today's edition of the Boston Globe:
Scientific research with an asterisk
By David A. Shaywitz and Dennis A. Ausiello
CONSIDER an academic scientist - we'll call him Louis - who receives funding from the beverage industry, the textile industry, and the livestock industry, and ultimately generates profound new scientific insights, beneficial both to the sponsoring companies and to the world as a whole. Are these accomplishments diminished because the work was industry funded? Should Louis - Pasteur - have an asterisk next to his name?
That's the implication of a recent
The notion that academic researchers who partner with industry are intrinsically tainted reflects a misunderstanding of the importance and quality of industry research, and the role industry plays in bringing new drugs to the patients who need them.
While most of the original insights leading to new drugs and devices likely derive, at least in part, from the work of academic scientists, turning these preliminary advances into FDA-approved treatments required an exceptional investment by industry, and vital partnerships between academic investigators and company scientists.
The gaping distance between promising lab result and approved drug is apparent to anyone who has tried to reconcile the breathless news reports touting "scientific breakthrough" with the paucity of options available for patients suffering from any number of devastating medical conditions. In the last 10 years, for example, there have been more then 7,000 academic papers published on pancreatic cancer, but not a single breakthrough treatment.
The primary reason for this gap: The human body is complicated, and our understanding limited. In many cases, we are still struggling to figure out the molecular basis for important diseases. In other conditions, even when the cause is clear, designing a drug capable of selectively correcting the defect while not causing new problems, is a monumental challenge.
To overcome these hurdles, there is a need for more, not less, interaction between academic physician scientists and their counterparts in industry, engagement that should occur at every stage of the drug development process.
Our own experiences with difficult science and sick patients has convinced us that the battle is not drug companies vs. academics, but rather between dreadful diseases and the medical researchers who are trying to subdue them.
Unfortunately, industry critics often lose sight of the big picture, and routinely stigmatize pharmaceutical researchers and their academic collaborators. Young academic investigators are often counseled against "selling out" and pursuing a career in pharmaceutical research, despite the exciting drug-development opportunities such a choice might afford. Senior university researchers who might contribute considerable wisdom to drug discovery efforts are reviled in the press if they associate with industry in any way, even though these relationships are vital for the creation of new medicines.
Finally, of course, there is the money. Because pharmaceutical companies are for-profit entities, conventional wisdom holds that any data they publish should be suspect. In fact, pharmaceutical research is tightly regulated, and industry-sponsored clinical studies are typically performed in a rigorous, consistent, and transparent fashion that would be the envy of many academics. To the extent some industry studies fall short, the problem generally lies not in the results obtained, but rather in the questions never asked - a critique that applies at least as well to the pharma-bashing studies now so popular in certain medical journals.
Also puzzling is the suggestion that it is improper for drug companies to solicit the perspective of academic experts, and immoral (or at least asterisk-worthy) for experts to accept financial compensation for their time. Expert insight may accelerate the delivery of new treatments to patients, and it seems disrespectful to suggest this time should not be valued.
Still, although the relationship between universities and industry should be broadened, useful and transparent guidelines must be developed to get this relationship right. Ultimately, these interactions must be defined, protected and enhanced if the medical community is to deliver on its commitment to secure the health and well-being of patients.
Dr. David A. Shaywitz is a management consultant in
"The real answer is -- we don't know. But if these ideas don't work the alternatives are largely disturbing: price controls, stifled innovation and stemming the spread of new technology. It gets ugly real fast."
Published: April 28, 2008
Drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff members and students in all 129 of the nation’s medical colleges, an influential college association has concluded.
The proposed ban is the result of a two-year effort by the group, the Association of American Medical Colleges, to create a model policy governing interactions between the schools and industry. While schools can ignore the association’s advice, most follow its recommendations.
Rob Restuccia, executive director of the Prescription Project, a nonprofit group dedicated to eliminating conflicts of interest in medicine, said the report would transform medical education.
Most medical schools do not have strong conflict-of-interest policies, and this report will change that, Mr. Restuccia said.
The rules would apply only to medical schools, but they could have enormous influence across medicine, said Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University.
We’re hoping the example set by academic medical colleges will be contagious, Dr. Rothman said.
"Drug companies spend billions wooing doctors” more than they spend on research or consumer advertising. Medical schools, packed with prominent professors and impressionable trainees, are particularly attractive marketing targets."
Okay.
Here are the facts from a November 2006 GAO report:
Drug companies spent less in 2005 on DTC advertising ($4.2 billion) than on promotion to physicians ($7.2 billion) or research and development ($31.4 billion). www.gao.gov/htext/d0754.html
Now some stuff Gardiner left out:
The Prescription Project is funded by trial attorneys who sue drug companies. IMAP gets millions from George Soros.
And the report never uses the word "ban.”
Here's what is does say, courtesy of Thomas Sullivan's blog:
www.policymed.com/
For Continuing Medical Education (CME)
Academic medical centers offering CME programs should develop audit mechanisms to assure compliance with the standards of the Accreditation Council for Continuing Medical Education (ACCME), including those with respect to content validation and meals.
Academic medical centers should establish a central CME office through which all requests for industry support and receipt of funds for CME activity are coordinated and overseen.
To the extent that educational programs for physicians are supported by any commercial entity, including pharmaceutical, device, equipment, and service entities, the programs should be offered only by ACCME-accredited providers according to ACCME standards.
In respect to CME these are all very reasonable recommendations, and most universities have already undertaken significant effort to achieve these goals.
The document covers many other things not directly related to CME including:
• Gifts to individuals (Prohibiting)
• Pharmaceutical samples, (Central Distribution)
• Site access by pharmaceutical representatives, (Limited to appointment or invitation, student participation limited, more MD’s, PhD’s and PharmD’s)
• Site access by device manufacturer representatives, (credentialing, appointment or invitation, disclosure and consent of patients, student participation limited)
• Participation in (Non CME) industry sponsored programs. (Discourage faculty, transparency of payment and fair market value, prohibit attendance, paying for attendance, accepting personal gifts)
• Industry Sponsored Scholarships and other Educational Funds for Trainees (Giving Centrally, no Quid pro quo, selection sole responsibility of the university)
• Food (only for ACCME-Accredited Events)
• Travel (only for legitimate reimbursement or contractual services.
• Ghostwriting (transparency of all involved in the process)
• Purchasing (Disclosure of interest, and recuse from purchasing decisions in COI cases)
• Boards of Directors, Advisory Boards and Consulting (Valuable and Compensation to Reflect Fair Market Value)
All the news that's fit to print?
Read More & Comment...
The study, published in the journal PLoS Medicine, concluded that the progress made in reducing deaths from cardiovascular disease, thanks to new drugs, procedures and prevention, began to level off in those years. Those gains, as they shrank, were outpaced by rising mortality from lung cancer, chronic obstructive pulmonary disease and diabetes. Smoking, which peaked for women later than for men, is thought to be a major contributor, along with obesity and hypertension.
Some, like former Senator John Edwards, are using the study to further fan the class warfare flames. And socio-economic conditions are certainly an important part of this issue but, as Sam B. Harper, an epidemiologist at McGill University who has studied the issue commented, “We know from hundreds of studies that income does have an impact on health, but it’s not a simple relationship."
Indeed. But politicians -- and especially frustrated ones like Senator Edwards, are always looking for simplistic, talking point-friendly answers to complicated problems.
According to one of the report's authors, Dr. Majid Ezzati, "... life expectancy disparities would have to be addressed through public health strategies directed at reducing the risk factors that cause chronic disease and injuries."
And that means a more deliberate effort at patient-based care -- focusing on earlier diagnosis (and better diagnostics) and more targeted health care (right treatment for the right patient at the right time). What it does not mean is a knee-jerk move towards "European" style healthcare and the ensuing cost-based rationing that inevitably comes with it.
For more detail on the study, click here: www.nytimes.com/2008/04/27/weekinreview/27sack.html
We mustn't allow the next generation of Americans to be the first in our nation's history to enjoy a shorter life than their parents. And to achieve that goal we must abandon the rhetoric of divisiveness and work together (government, academia, and industry) towards this common purpose.
Read More & Comment...
"I think in some cases you are probably right about the failure to conduct Phase IV studies being a "self-inflicted" wound, but there is perhaps a bigger problem in the design of a lot of the studies. Once a drug is approved and deemed safe and effective (in many cases proven in compelling fashion despite the absence of a perfect p-value), conducting randomized studies where patients are randomized into treatment arms that do not serve their best medical interests is fraught with all kinds of ethical and practical problems, and challenges for sponsors, physicians and doctors. Coupled with the undeniable fact that after approval the development and learning process about many drugs accelerates dramatically (a good thing that usually leaves the slow-moving FDA far behind) often causes the trials mandated by FDA to become obsolete before they start, and even more commonly before they are completed. When that occurs, the FDA's and other's mandates that the trials be conducted anyway degenerates into nothing but a form over substance pursuit of compliance for no other purpose than compliance. That should not be the purpose of the regulation of medical products because it is harmful to the public health, not to mention a waste of money and patients.
Thanks Steve -- for both the thoughtful comments and for giving me the benefit of the doubt.
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 Read More & Comment...
content.nejm.org/cgi/content/full/358/17/1774 Read More & Comment...
“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.
Read More & Comment...
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.
Read More & Comment...
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.
Read More & Comment...
"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 Read More & Comment...
www.nypost.com/seven/04202008/postopinion/postopbooks/foul_shots_107320.htm
Read More & Comment...
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?
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