Advocacy and Genetics: Who Owns Your Genes--and to What End?

On February 13, Michael Crichton published an op ed piece in the New York Times on gene patenting. Crichton’s piece argued that genes should not be patented:

Gene patents are now used to halt research, prevent medical testing and keep vital information from you and your doctor. Gene patents slow the pace of medical advance on deadly diseases. And they raise costs exorbitantly.

Crichton’s piece has been widely read, discussed and blogged about, including a thoughtful discussion of whether gene patenting is consistent with other patenting in scientific discovery or unique by Derek Lowe in the blog Corante.

The patenting of isolated genes as chemical entities is tricky. Yes, they are chemicals, and when they're isolated and purified like that they really are in a different state than found in nature. But their size is so far removed from many of the other things patented as substances that I can't help but wonder if a principle is being pushed too far. (The obvious other example here is the patenting of isolated proteins, which of course is also well established, for better or worse).

The patent law argument rests on a 1980 Supreme Court Decision in Diamond v. Chakrabarty, and is presented briefly along with a summary of arguments for and against gene patenting on the Human Genome Project Information web site.

Prior to 1980, life forms were considered a part of nature and were not patentable. Diamond v. Chakrabarty changed this with the 5 to 4 U.S. Supreme Court decision that genetically engineered (modified) bacteria were patentable because they did not occur naturally in nature. In this case, Chakrabarty had modified a bacteria to create an oil-dissolving bioengineered microbe.

In an unpublished letter to the New York Times (Feburary 14, 2007), Peter Arno,who teaches Health Economics in the Sarah Lawrence College Health Advocacy Program, and his colleague Michael Davis, wrote this response to Crichton’s piece.

Michael Crichton is right on target when he argues that gene patents inhibit medical innovation. However, this argument can be taken even further. In terms of new drug development, there is scant evidence that patents stimulate biomedical research or innovation. What they certainly do is protect the monopoly profits of multinational drug firms. Rather than stimulating creative drug development, patents promote the sale of high-priced drugs and massive expenditures on marketing pharmaceuticals for conditions prevalent in wealthy countries for which treatments already exist (better known as “me-too” drugs). What makes matters worse is that the Patent Office rejects an appallingly small number of applications. A good patent lawyer, it is said, can get a patent on a ham sandwich. When a patent system is so out of control, it is not surprising that innovation suffers.

[Note: A useful review of “the negative consequence of gene patents” can be found in Greenpeace’s report on The True Cost of Gene Patents: The Economic and Social Consequences of Patenting Genes and Living Organisms which summarizes these consequences as follows:

• considerable increase in the burden on patients and health insurance funds
• protracted litigation that may also severely impede research and development
• a blockade of research and development by whole bundles of patents to be observed for individual technical innovations
• hindrance to medical institutions, particularly in the field of diagnosis
• obstruction of current proteomics research by hastily granted and too extensive gene patents
• impediment of research and development, particularly in the field of infectious diseases
• unacceptable dependence of patients with hereditary diseases on individual companies
• danger to world food supply owing to the exorbitant cost and monopolization of seeds
• new systematic dependence of medium-sized plant breeders
• considerable financial risks and direct dependence of farmers
• stepping up of international concentration process in the seed industry
• new dependence of food industry on agrochemistry]

The issue of gene patenting has become central to the work of many patient advocacy organizations seeking to not only promote research related to particular genetic disorders, but to ensure that the voice of the patient—and the family—is part of the research planning process. These groups understand that in today’s research “marketplace,” the fact that very real people—often children—are the source of the tissue samples that enable researchers to find gene mutations, should mean that they are able to continue to play a role in the use of that research for testing or treatment. In another New York Times piece earlier this year (“Someone (other than you) may own your genes”), Denise Caruso, executive director of the Hybrid Vigor Institute, noted this concern and raised the example of families affected by the Canavan disease:

The degree of control that life patents grant their owners is of growing concern to scientists, human rights and patient advocates and ethicists. More than 20 percent of human genes have already been patented, and most of those patents are owned by corporations.

. . . . In the case of the Canavan disease patent, for example, a family afflicted by this rare genetic disorder initiated an effort to find the gene mutation responsible for the disease. They raised money, collected DNA samples and attracted researchers to the cause.

After a researcher found the gene in the late 1990s, he and his employer, Miami Children’s Hospital, patented it and began charging royalties on a genetic test to screen for the disease — despite the fact that they would never have found the gene without the efforts and the DNA samples of the afflicted.

Patient groups filed suit in 2000, contending misappropriation of trade secrets by using their children’s DNA without consent to obtain a patent. It took until 2003 for the parties to reach a confidential settlement; it allows certain laboratories to continue collecting royalties but lets institutions, doctors and scientists use the patented gene sequences without paying.

At the end of March, the two certificate programs at Sarah Lawrence, Applied Research Ethics and Public Health Genetics/Genomics, will come together to discuss with speakers and panelists ethical issues related to genetics and research. The Canavan Foundation situation and subsequent efforts by patient advocacy groups to control tissue banking and gene patenting, will be a focus of some of this discussion. Yet in the background now is advocacy of another sort: advocacy focused on pending Congressional legislation aimed at protecting the broad public interest. The “Genomic Research and Accessibility Act,” introduced by Representative Xavier Becerra, Democrat of California, and Rep. Dave Weldon, M.D. Republican of Florida, would “prohibit the patenting of human genetic material.”

Clearly discussion and dialogue between advocates in different arenas around these gene patenting issues is only beginning, but its importance is unquestionable.

Overturning Insurance Denials: A Cautionary Tale

Its great to win a hard one. One of the things I do is to file appeals for people who have been denied payment by their managed care company. As Paul Krugman recently wrote about in the NY Times, a good portion of the costs of health care is spent by insurers paying the small army of administrative denial managers. Too often someone will call me after they have made their first appeal and blown their timely filing guidelines clearly stated in the fine print of every insurance contract. Once the 45 days are over (a typical time limit), if the patient hasn’t responded, they lose. That medical bill is theirs.

My case was a woman who went over seas and got pneumonia. Trying to do the right thing, she immediately called her insurance company with information that she had been hospitalized.

The denial came before she even got home: lack of medical necessity. All inpatient admissions are subject to concurrent review. Since my client was overseas in a way-out-of-network hospital, the insurer lacked any way to coordinate care.

One big problem was that when I got the case it was over a year old – timely it wasn’t. But I was able to find a clause in the contract where I could press the case, so I sent it out for external appeal to the Insurance Commissioner. You would think this office is there to protect consumers: not so. They, too, made a finding about lack of timely filing. See, the clock started ticking from the moment medical records were received. Apparently a phone call from a different continent was enough of a medical record for the IC’s office to blow us off.

But I had also sent the same appeal back to the original insurer, who called to ask, “What medical records?” I had attached 11 pages of medical records to these appeals, which were mysteriously removed before the appeal got out of the mailroom. Only the careful wording of my letter made the examiner call and asked me to fax the documents directly to her. And, we lucked out with the examiner, too. He gave us a fighting chance.

Voila! We won!

External Appeal? Don’t count on it. Unless you can demonstrate real malfeasance, I’m afraid your case won’t get a fair shake.

Cross-posted at http://trusted.md/columns/medical_bill_advisor

Following the Blogging Trail

The trail started with a Google Alert: The Antidote to Simplistic Health Journalism, an interview by Nicholas Genes, second-year resident in emergency medicine, at Mount Sinai Hospital in NYC, with Emily De Voto an epidemiologist who blogs on The Antidote. DeVoto's goal is to promote evidence based health journalism--and health care. A huge undertaking.

One of DeVoto's blogging trails leads to the debate over obesity and its relationship to morbidity and mortality. DeVoto links us to the blog, Junkfood Science in which Sandy Szwarc reviews the campaign by the CDC to link obesite to mortality in the US and thus frame obesity as a public health problem. A study by Katherine Flegal published in JAMA challenges that construction (see Junkfood Science for important excerpts). As Szwarc concludes:

The whole “obesity” thing has been an easy sell because our culture has come to believe so strongly that thin is better and fat is bad, and so loves to hate fat people, that the idea of questioning it is inconceivable.

It is well worth browsing through The Antidote. Note especially, DeVoto's Grand Rounds. In December Grand Rounds included 37 links to other health bloggers in arenas ranging from Mental Health to Research to Policy, Public Health, and Insurance, and leading off with "In The Trenches," which loosely means bloggs by clinicians "in the front lines of practice" (although there are certainly other trenches in health care, including the trenches of health system change which more clearly resemble WWI death traps for advocates and politians alike).

Finding DeVoto's blog struck a responsive cord this week when I have particularly sensitive to issues of evidence-based practice and the lack thereof. We are engaged in a family "discussion" over the risks and benefits of Procrit for an elderly family member. (Procrit is epoetin alfa used to treat anemia, usually in people with serious kidney disease or as a result of chemotherapy for cancer, medications for HIV, or to prevent or treat blood loss before or after surgery.) Without belaboring the debate, it really revolves around the off label use of Procrit recommended by the cardiologists involved. Some of us are uncomfortable proceeding with Procrit for off label use without the evidence of treatment risks and benefits to guide us; others in the family feel that if a physician makes a recommendation, s/he can and should be trusted to know what is best. Anecdote vs. data again. Or, as DeVoto notes in her profile: "The plural of anecdote is not data." As advocates so many of us in the Health Advocacy Program face at home exactly the advocacy issues we research, discuss and act upon with school and work. Contextualizing these issues within a family dynamic, within the cultures of belief, within the clinician-patient or clinician-family relationships creates layers of meaning and nuances of communication that humble each of us. Would that prospective advocates and clinicians alike could have required experience as cared for and care giver.

“Just” listening no more…

The following blog is from our colleague, Meg Gaines, founding director of the Center for Patient Partnerships at the University of Wisconsin, Madison. Meg is a fellow educator of advocates--graduate students from the many graduate and professional schools at U Wisc who take courses in patient advocacy and learn to be advocates in a supervised clinical program that serves patients and family in need. These thoughts about listening have become crystalized for Meg as she and her colleagues plan a new training program in patient advocacy for lay breast cancer advocates in the community. They seemed useful for all of us who work on our listening skills in order to hear, and thus to serve.

Words are so powerful – even little, qualifying words like “just.” Over the last few years, I have often asked students and colleagues what they did for a particular client only to hear them reply that they “just listened.” As if listening to someone is somehow minimal. As if listening to someone is anything less than an act of profound honor and respect. As if listening isn’t one of the most difficult things to do well. There’s nothing “just” about truly listening.

Listening requires me to set aside my own agenda. It necessitates that I suspend my judgments – sometimes dozens of them in a matter of minutes. I am called upon to put down my pen, turn away from my list of things to do, take my eye off my watch, forget about all the conversations I am reminded of as this person tells this story, fend off my overactive brain’s constant suggestions of what I would do if I were faced with this dilemma. Listening requires active focus. It requires me to step entirely outside of myself and take in what is being said in relation to the speaker – not in relation to me. Listening is hard work.

I suspect that “just listening” derives from the kind of self-focused, I-can’t-wait-until-she’s-done-talking-so-I-can-tell-her-my-story-which-is-much-more-amazing-than-hers sort of interactions that I, at least, have more of than I like.

Real listening happens when I slow down enough to set my life aside for a moment and notice, honor and accept another being into the space in front of me. It is work right up until I let go of me and settle into another. Then, it is peaceful and rejuvenating – it is that profoundly precious gift that comes from giving.

Take a moment sometime soon to set your self aside and listen deeply to someone else. Stay with it, even as your mind wanders through Judgment Junction and Suggestion Swamp, redirect it gently to the miracle life force placing this profound trust in you. Try to hear, see and absorb the significance of the words to their speaker. There is nothing “just” about this listening.

“Astroturf” Advocacy

Earlier this month an article in Newsweek online (October 5, 2006) reported that there was a growing movement among medical centers—mainly it seems academic medical centers—and some physician groups to ban or regulate gifts from pharmaceutical companies. This includes token freebies—pens, notepads, post-its—from sales reps as well as more significant amounts spent for free lunches, underwriting educational programs and conference travel stipends. While the 24, 2006, “Doctors Urge Ban on Gifts From Drug Makers”)

Unfortunately there has been much less attention paid to pharmaceutical support for health/patient advocacy organizations, although potential conflicts of interest are similar and serious. On my office closet door I now have hanging a conference bag in which I am accumulating “trinkets” given away at health/patient advocacy conferences, mainly contributed by pharmaceutical companies who have helped sponsor the conferences. Many—perhaps most--advocates are only too painfully aware of the dilemmas they face regarding whether to accept pharmaceutical funding for their struggling organizations—how to do their valuable work without taking money from the very corporations that benefit from the diseases they are trying to fight.

The title of this blog comes from Drummond Rennie, deputy editor of JAMA, who calls advocacy organizations that are almost extensions of pharmaceutical company marketing departments, “Astroturf.” “Astroturfing in politics is the practice of disguising an orchestrated campaign as a spontaneous upwelling of public opinion.

A recent study done by New Scientist, “Patient groups special: Swallowing the best advice?”, sheds some light on the extent to which pharmaceutical and device companies fund patient advocacy organizations in the US.

New Scientist studied 29 US patient advocacy organizations:

o 20 US patient groups operating on a national level with annual revenues of more than $100,000 (randomly selected from GuideStar database)
o 5 US patient groups with revenues exceeding $10 million (randomly selected from GuideStar database)
o 4 US patient groups, again with annual revenues exceeding $100,000, associated with bipolar disorder, restless legs syndrome and attention deficit hyperactivity disorder, conditions highlighted in April by the journal PLoS Medicine as being susceptible to by the pharmaceutical industry.

Some survey results:
· Seven groups received 20 per cent or more of their funding from pharmaceutical and medical device companies, including all four linked to the conditions over which accusations of disease-mongering have been made.
· Groups that received more than 20 per cent of their funding from industry did seem to be associated with conditions that affect a significant number of people, for which a specific therapy exists and which require long-term treatment, therefore creating the potential for substantial profit.
· Groups in our survey that received no industry funding seemed to be for diseases that drug companies have little opportunity to profit by.
· The timing of donations also suggests a link to marketing interests, with donations to the advocacy group ceasing if the company stops producing drugs related to the disease.
· Just two groups - the National Women's Health Network (NWHN) and Breast Cancer Action - refuse to accept donations from pharmaceutical or medical device companies. "We want women to know that when they come to us, they are getting independent information," says Amy Allina, the network's programme director. "We think of ourselves as virtuous, but poor."
While patient groups deny any connection between their activities and the donor support they receive, a “gift relationship” does exist, say researchers.

Sharon Batt of Dalhousie University in Halifax, Canada, has just begun to study patient group behaviour and funding after years working in breast cancer advocacy, where she noticed a general pattern. Organisations that accept pharmaceutical funding "tend to advocate for faster review and availability of drugs, greater insurance coverage, and they tend to see 'direct-to-consumer' advertising as a benefit to patients." Groups that maintain financial independence, on the other hand, "emphasise safety over speed and are critical of direct-to-consumer advertising."

Complete disclosure of industry funding by patient groups is almost unheard of, but the massive American Heart Association, which boasts an annual revenue of more than $650 million, is leading the way. This month, it will begin posting an itemised list of pharmaceutical and medical device company donations on its website.

Sick of Pink

We are starting up blogging again in October. How did I know it was October? Pink of course. First the emails from online catalogues soliciting my business by promising contributions to breast cancer research or advocacy. On my home email, Activa Sports beat out the competition with a whole “Pink Ribbon Collection." Then a friend who has had breast cancer sent out a mass email asking me to forgo my health concerns for a good cause and buy pink M&Ms.

October is National Breast Cancer Awareness Month, and to commemorate, we've created a special pack of M&M'S® Chocolate Candies. Each time you buy one of the specially marked bags, we'll make a donation* to The Susan G. Komen Breast Cancer Foundation. Help support breast cancer research and outreach programs while satisfying your sweet tooth!

Later in the month, the tempting email arrived telling me that the Entertainment Industry Foundation’s breast cancer programs would be delighted if I could purchase a pair of jeans for Lee National Denim Day thereby contributing $5 to the cause. Or, if I prefer, I could hold a special event—ideas available on the Lee web site—and just wear my Lee jeans to the event.

In search of more pink to buy I came across a megasite that not only lists all the sites that have “gone pink” to support breast cancer awareness, but cruises the web constantly for automatic updates: Pink for October. On this pink site was a breathe of non-pink air written by “jeanne” of The Assertive Cancer Patient blog. What caught my eye was the opening line, “I hate pink.”

When I was a “tomboy,” as girls who rode bikes and climbed trees were called in the 1950’s, I hated pink. Even as a preteen I knew that pink symbolized the stereotypes of ultra girliness. Today, of course, this color, the symbol of sexist stereotyping, becomes a metaphor for a mainly female illness. As a social marketing campaign it is very effective: now pink is forever associated with breast cancer, and presumably a new kind of “girly” assertiveness. Color branding of diseases and causes, I suppose, serves a certain purpose (red=HIV/AIDS; yellow=Lance Armstrong style cancer; green for genocide in Darfur), but as an advocate, it is difficult to believe in the long term benefit of teaching people to treat diseases the way they treat their favorite sporting teams: wear the colors and cheer for bigger and better results. The bigger results may include more research dollars for breast cancer but at the price of supporting a growing industry that is benefitting commercially from the disease.

Here is a section of jeanne’s essay with an important message. Check out her blog for the rest.

Gag Me With a Pink Ribbon
October 24th, 2006 by jeanne

I hate pink,especially the pink ribbons. I really do. I don’t understand what they are for… support and solidarity, something like that, but I’m not getting that from a little twist of pink metal pretending to be a ribbon.
. . . .
Instead of pink ribbons, I’d rather have national health insurance or any health insurance plan that insures SICK people. The way things are now, if you are young and healthy, you can get health insurance at a reasonable cost. If you are old or, God forbid, sick, forget it.

If you want to support people with cancer, forget the ribbon and lobby for national health care. Or for a state health insurance plan that is open to everyone, rich and poor, sick and well.

. . . .

Narrative, Advocacy and AIDS at 25

It has been almost a month since any of us blogged on this site, which has nothing to do with the amount we have to say, and everything to do with completing the academic year and squeezing intense activity into the early part of June. For many of us involved in the Health Advocacy Program, these weeks have been opportunities to focus on the role of narrative in health & medical care, in advocacy and in teaching. We participated in the Narrative Matters conference at Arcadia University in Wolfville, Nova Scotia (just right for escaping the NYC metro area in late spring) where I chaired a panel on “Listening to the patient’s voice: An interdisciplinary approach integrating oral history, illness narratives and advocacy” that included Sayantani DasGupta, a pediatrician and Health Advocacy faculty member, and Pat Stanley, an alum. (Sayantani also delivered a second paper—an amazing combination of analysis, performance and media, “Cameras, scalpels and speculums: Popular film and the tragicomedy of pelvic exams.”) See Conference Program for other interesting papers.) Sayantani and Pat have also been faculty in the new Narrative Medicine Workshops at Columbia. This week the Writing the Medical Experience workshop begins at Sarah Lawrence. For the second year at the College, David Watts, physician and poet, is coordinating this intensive writing experience where professionals, patients, health consumers and caregivers teach, write, support, critique and listen to each other. (Evening readings by faculty are open to the public if you are in the area.)

I was reminded of the power of narrative and the role of narrative in advocacy last week when I read Abraham Verghese’s beautifully written op ed piece in the New York Times on “AIDS at 25” (New York Times, June 4, 2006, not yet online as of this writing). Verghese was a young medical resident 25 years ago when AIDS struck New York. "[T]he milestones of my life and medical career -- and of thousands of other doctors like me -- have since been inextricably tied to the history of the virus,” he writes. He went on to write My Own Country about caring for—and about—people with AIDS in east Tennessee during the next decade. Today he teaches medical students not yet born in 1981 “how the metaphorical veil of shame and secrecy that traveled with this virus tainted everything; how being an AIDS doctor could distance you from other doctors, and even from friends.” Verghese’ tribute to these early sufferers from AIDS, and to those who cared for them, is a tribute all of us in the advocacy community share:

My patients taught me about courage, about bravery, about organizing for a cause, about dying for one. . . .

We became zealots for the cause of our patients, even if zeal was all we had to give. We had no cure to offer, and so we began to leave the thresholds of our medical-industrial complexes and visit our patients in their homes, at their deathbeds. Paradoxically we discovered that our presence, our promise not to desert our patients, our continued care brought about a sort of healing, by which I mean helping the patients come to terms with their illness, with their deaths, and meanwhile diminishing for them the sense of spiritual violation that any serious disease brings, none more than this one.

. . . I watched with awe as politics eclipsed science and as gay activists rattled the cages of stodgy government entities like the Food and Drug Administration, and got results.

. . . Today I see so many of us who came of age at the same time now have one foot in Africa or Asia, as if we need the kind of challenge we once faced here. It is as if we have carried the lessons of the AIDS protest group Act Up abroad, to prove that one can make a difference even in a poor country, one can find ways to pay for and distribute drugs, one can make an impact on transmission from mother to child.

. . . On my desk I keep a picture sent to me by a friend, Rick Hodes, a doctor who has spent his professional years in Ethiopia. It shows a beautiful, chubby-cheeked Ethiopian child, wearing colorful local dress, and holding in his hand a photograph of a scrawny skeleton in rags. The photograph is of his former self, taken a few months before he got the H.I.V. medications that Rick scrounged money to buy. Victories are now to be won in that fashion, one child at a time.

. . . I think perhaps that is the legacy of my patients, the legacy of the nurses and physicians' assistants and social workers who taught me so much, the legacy of people from all walks of life who toiled against AIDS when there was no hope. My students seem to know what we had to so painfully learn: the secret in the care of the patient is caring for the patient.