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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?
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.
"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
content.nejm.org/cgi/content/full/358/17/1774
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.
