January 6th, 2009 by Dr. Val Jones in Uncategorized
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The Office on Women’s Health (which is part of HHS) recently sent me a book to review: The Healthy Woman – A Complete Guide For All Ages. It is on sale at the U.S. Government bookstore. The book says that it provides “easy to understand information from the nation’s leaders in women’s health.” And I agree that it lives up to that promise.
When I receive a general consumer health book there are a few sections that I generally read first to determine whether or not the book is trustworthy: complementary and alternative medicine (CAM), nutrition, and hormone replacement therapy. The Healthy Woman passed my test on these subjects, though I could quibble with some of their content. For example, they suggest that homeopathy requires “more research” to determine it’s potential therapeutic uses – one could say the same for fairy dust I suppose, though I wouldn’t waste tax payer dollars on that research. I also think they overstate the literature on salt consumption (for people without renal failure, CHF, or severe hypertension, there doesn’t seem to be much reason to worry about salt intake in my opinion).
However, overall the book does an admirable job of synthesizing the scientific literature in a simplified and consumer-friendly form. Compared to other books I’ve been sent by supposed “health experts” (which were so filled with pseudoscience that I declined to review them), this one is outstandingly good. By and large it can be relied upon by readers to provide an accurate introduction to the various diseases and conditions likely to affect women at various ages and stages of life.
A few shortcuts were taken in creating this book – Getty images replaced original photography in many instances, questionnaires were adapted from research literature without careful thought being given to the likely readership (one screening questionnaire asks the reader if they’re “living in prison” or “blind”), no original research studies are cited in the reference section of the book, and the medical glossary is quite sparse (I noted only 6 entries under the letter “v,” one being “voyeurism.” I had not expected that particular v word would make it into the top 6 in a general medical text, but I digress.)
The book is written at a sixth grade reading level which is appropriate for the general public. It is a fine introductory reference guide to women’s health – though I doubt that women will want to read it cover-to-cover, but rather delve into the sections relevant to them.
The strength of the book lies in its plain writing and accessible format. Its weakness is that, because it covers all diseases and conditions that affect women, it does not offer the kind of depth necessary to master any of the health topics.
In the final analysis, I’m grateful that this book exists as a counterbalance to the sea of misinformation constantly churned out by publishers looking to turn a profit on “miracle cures your doctor won’t tell you about.” Thank you, HHS for making the effort.
*Purchase the book here*
January 6th, 2009 by Dr. Val Jones in News, Opinion
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Thanks for the cute photo, Dr. A!
January 5th, 2009 by Dr. Val Jones in Book Reviews
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Well this is really exciting! Thanks to the readers and judges at Medgadget.com for acknowledging my blog for a 2008 Blog Award in the category of Health Policy and Ethics. (This blog won the “Best New Medical Blog” of 2007 award last year.) This year’s winner will be determined by popular vote, which begins tomorrow. I know that my chances of winning the majority of votes in this category are pretty slim, thanks to Respectful Insolence. I am a huge fan of Orac’s blog and have no doubt that his contributions in this category far exceed mine. Orac is a devoted crusader against pseudoscience and misleading health information. Good luck, Orac – I’m sure you’ll win this one!
January 5th, 2009 by Dr. Val Jones in Audio, Uncategorized
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Amy Tenderich
Amy Tenderich is a leading online voice for diabetes advocacy. She is author of the popular blog, Diabetes Mine, and has type 1 diabetes herself. I caught up with Amy recently to discuss her concerns about a potential slowdown in diabetes research due to an increasingly risk-adverse FDA. You may listen to our conversation here, or read my summary below.
[Audio: http://blog.getbetterhealth.com/wp-content/uploads/2009/01/amytenderich.mp3]
Dr. Val: I understand that there’s a new petition asking the FDA to better serve the needs of people with diabetes. What is your role in that?
Tenderich: The petition represents the collective online voice of the diabetes community. It was spearheaded by Kelly Close, Manny Hernandez, and myself in response to what seems to be an increasing climate of extreme risk aversion on the part of the FDA. Patients generally don’t know much about the FDA’s actions, so we bloggers are stepping in to raise awareness.
Dr. Val: What do you think is making the FDA so risk-adverse?
Tenderich: As noted by Rebecca Killion, one of the few Patient Representatives who works directly with the FDA (and also has Type 1 diabetes), we’ve seen intensified regulatory issues in the post 9-11 era due to an increasing culture of fear. In addition, this country is so litigation happy, that everyone is trying to cover themselves. The media tends to dramatize things and they come out with headlines like “diabetes drugs will kill you.” In reality, certain drugs may be very helpful to millions of people, with caution only required for those in high risk groups. We need to counteract some of this fear and exaggeration by having patients speak up. We can’t just be yanking whole classes of drugs off the market because of a risk found in a small subgroup of potential users.
Dr. Val: Can you explain how the FDA’s new safety requirements might stymie diabetes research?
Tenderich: The FDA is adding additional cardiovascular research requirements to the development of all new oral diabetes drugs. This will have a chilling effect on innovations in diabetes care. As Rebecca has pointed out, it’s pretty unreasonable to require cardiac testing in phase II and phase III drugs that have not given us any reason to believe that they may pose a cardiac risk. The additional expense and time lag caused by testing the drugs for potential cardiac side effects will slow down the whole process and makes some research cost-prohibitive for smaller companies. It takes thousands of additional study subjects to rule out the possibility of cardiac harm, which can add up to tens of millions of dollars.
Patients put a lot of faith in the FDA and they just assume that it’s looking out for their best interest – both in terms of mitigating risks and also in regard to encouraging research in the right areas. However, the FDA can be very political – with individual researchers driving their own agendas, without specific regard to patient needs. The diabetes community would definitely like to see a stronger patient voice at the FDA.
Dr. Val: So in a perfect world, what changes are you hoping that the next FDA Commisioner will make?
Tenderich: We’d like to see the new Commisioner remove excessive research hurdles to pave the way for new drugs and innovations. Of course we want the FDA to keep safety in mind and issue warnings to appropriate at-risk populations, but we don’t want them to remove patient and physician choices. We’d like to see the FDA help (rather than hinder) the development of new technologies to improve quality of life, such as continuous glucose monitors. These devices can make a huge difference in diabetes management, but insurance companies are pushing back hard on coverage for them because of the high up-front costs for a long term gain.
The purpose of the petition is to implore the FDA to set up a Diabetes Advisory Council made up of patients, researchers, and physicians “in the trenches” and actively engaged in diabetes care on a day-to-day basis. That way the decisions made by the FDA will be more in tune with the needs of real patients.
To sign the petition, please go to www.healthefda.com.
For more information, please check out Amy’s blog post at Diabetes Mine.
January 4th, 2009 by Dr. Val Jones in Opinion
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I was a little surprised by a recent reader comment suggesting that pharmaceutical companies are no different than tobacco manufacturers. While I am strongly opposed to misleading pharmaceutical marketing tactics, the bottom line is that most drugs have a legitimate therapeutic value. Tobacco, on the other hand, is a known carcinogen with no medical value that I can think of. This comparison, however, brought into focus a common underlying assumption: that for-profit companies are inherently less ethical than non-profit and academic centers.
I’d like to question the tendency to absolve academic centers of any possible wrongdoing on the basis of their educational reputation or non-profit status. Of course, financial gain is not the only motivator behind endeavors, initiatives, and behaviors – though it may be the easiest to measure.
As a medical student I witnessed a sad example of academic misbehavior. Senior residents in the department of plastic surgery were performing liposuction procedures after hours for cash. When a patient experienced an infectious complication from a thigh liposuction procedure, an investigation ensued. The residents claimed to be putting the cash into the residency fund, to be used to support travel, lodging and participation in annual assemblies – therefore exonerating themselves of wrong-doing.
It is unclear if the department chair was fully aware of what the residents were up to, though he was reprimanded, terminated, and ended up teaching at another institution. The plastic surgery department lost its accreditation, and all of the residents had to finish their training elsewhere. As for me, I lost my mentor (the department chair) and ended up not pursuing a career in surgery. There certainly was a lot of fall out from that debacle on all sides.
A case of academic double standards was highlighted recently by Dr. George Lundberg in a Medscape editorial where journal editors claimed that continuing medical education (CME) courses should never be sponsored by for-profit companies. Meanwhile the journal accepted advertising from these same companies:
…The JAMA editors who wrote in 2008: “…providers of continuing medical education courses should not condone or tolerate for-profit companies…providing funding or sponsorship for medical education programs….” This is from a publication that, for more than 100 years, has been supported primarily by advertising revenue, mostly pharmaceutical. The editors will say “yes, but we follow rules to prevent bias or improper influence.” True. So do we, a for-profit company, follow rules that prevent bias and improper influence.
On the positive side, there are many examples of for-profit companies who cultivate a culture of environmental responsibility and charity – Ben & Jerry’s, SC Johnson, and Patagonia come to mind. And let’s not forget the foundations created by Bill and Melinda Gates, Warren Buffet and many others thanks to overflow from for-profit endeavors.
In the end, conflicts of interest, hidden agendas, and secret quid pro quos are a matter of individual character and corporate culture. The people who build a company (or a country) have more to do with its behaviors and processes than the simple label “for profit” or “non profit” or any assumptions made at such a superficial level.
We are all biased in many ways, both consciously and unconsciously. The best we can do is to strive for transparency. It may be best to judge each entity and/or individual by their degree of transparency rather than profit status, academic status, or subject matter expertise. For-profit companies can be highly ethical, and academic centers can be rife with undisclosed conflicts and questionable behaviors.
Healthcare organizations should not avoid or incur scrutiny based on their profit status alone. Bias comes in many forms – and the best we can do is work for the good of others in full knowledge of the influences around us.
The Office on Women’s Health (which is part of HHS) recently sent me a book to review: The Healthy Woman – A Complete Guide For All Ages. It is on sale at the U.S. Government bookstore. The book says that it provides “easy to understand information from the nation’s leaders in women’s health.” And I agree that it lives up to that promise.
