#ahcj11

This past week I attended my first conference of the Association of Health Care Journalists, aka #ahcj11. I was initially drawn to the meeting by seeing that some of my favorite bloggers—Maryn McKenna, Pharmalot, Scott Hensley—were moderating panels. The conference far exceeded my expectations. While neither my fingers nor my mind have the agility to live tweet, here were some of the highlights for me:

Workshop: Mapping and charting health in your area

Introduced me to neat mapping that can be done with Google’s Fusion Tables. I’m a visual person, so love the ability to display reams of data visually, such as global patterns in TB. Later, I was also impressed by esri’s GIS mapping capabilities.

Workshop: What are your criteria in reporting on health care research?

This session, on critically reviewing stories, was excellent. Th-e session and the accompanying book, “Covering Medical Research,” taught more about how to evaluate articles than I received throughout my medical training, sadly enough. Gary Schwitzer’s Health News Review uses this approach, and is a valuable resource. Schwitzer’s point about differentiating stenography from journalism is broadly applicable and well taken.

Later sessions included a briefing by Donald Berwick, an overview of nanotechnology in cancer, and Francis Collins’ perspective on NIH research. Given my own clinical research background, I found the talks on problems in drug development, detecting fraud in medical research, and James Wilson’s lessons from gene therapy trials (Jesse Gelsinger) gave valuable perspectives.

Overall, the knowledge of many of the speakers and of the journalist questioners was impressive, with many perceptive, pointed questions being addressed to the panelists.

I even felt comfortable enough with the group to raise questions of my own.

One of the most provocative sessions was that on food safety. I’ll have more on that in my next post.

Photo courtesy Pia Christensen, ahcj

Like horror flicks? Read this…

I used to worry about MRSA…then I started seeing multi-resistant Gram negative bacteria in the hospital, like the carbapenem resistant (KPC) Acinetobacter I mentioned in my last post, usually infecting nursing home or chronic ventilator patients. That pales in comparison to the impending wave of infections caused by bacteria carrying the NDM-1 gene. NDM-1 stands for New Delhi Mettalo-beta-lactamase, an enzyme that chews up the “beta-lactam” ring, which is the backbone of many antibiotics, rendering them useless. NDM-1 was first described in a patient from India in 2008. Last year, a cluster of cases was described in 180 patient isolates. A common denominator was that most of the patients had received medical care in India or Pakistan.

As I’m preparing to go to India with a group of students next month who want to study public health, I was particularly struck by this week’s unsurprising news that the NDM-1 carrying bacteria had been identified in Delhi tap water and in standing water in the city—I said unsurprising, having seen some of the lack of sanitation first-hand.

What makes NDM-1 scarier than other recent superbugs is its ability to transfer its genetic material more readily. Part is because the transmission occurs via plasmids, small extra-chromosomal bits of DNA. Another part is that the transmission between bacteria can occur at water temperature, facilitating the spread in sewage-contaminated water. India also has a high rate of people without access to good sanitation or clean water, diarrheal disease, and access to over-the-counter antibiotics, all of which serve as enhanced breeding grounds for transfer. Even worse, the NDM-1 resistance gene is able to transfer to common bacterial pathogens there, such as cholera, typhoid, and the ubiquitous E. coli.

On my first trip to India, as the train approached the station in Delhi, I was rather shocked to see men lined up along the river like this:

Now take a look at this graph of antibiotic drug development from IDSA, to commemorate World Health Day:

Scary, isn't it?

Until CA-MRSA (community acquired MRSA), superbugs were fairly predictably associated with ill people and healthcare associated infections.

But now, this NDM-1 has now been isolated throughout the environment in one of the world’s most densely populated cities...and will soon spread globally.

Add to that the way antibiotics are squandered, irresponsible detailing by pharma and misuse by agribusiness…and you understand the insomnia...

A minor hope—may the student’s trip remain academic, and not become an experiential study.

(photo from drmuir.wordpress.com)

Superbugs and Seasons

Besides MRSA, other superbugs are now vying for our attention. A few months ago, NDM-1, from India, was creating a furor. A new article, by Maryn McKenna, focuses attention on Carbapenem resistance in Klebsiella pneumonia and clearly outlines how this form of resistance occurs. But there is one element fueling this growing problem of resistance that is not often touched upon—that of the public’s unreasonable expectations about care.

For example, I saw another patient last month who was minimally responsive, with little likelihood of recovery. This patient was colonized with a carbapenem resistant Acinetobacter baumanii which, like the KPC, was susceptible only to colistin, a highly toxic antibiotic. Years ago, when I started practice, families understood when doctors said, “Nothing can be done.” Patients were allowed to die in peace, with the emphasis being on comfort. Now, many families appear to believe in the immortality of their loved one and want “everything” done—no matter the cost in money, pain for the patient, or the danger to others. In the current U.S. environment, families have a sort of magical thinking in the ability of technology to prolong life, and an inability to accept death as a part of life. This leads to their demands for care beyond what seems reasonable for both the patient and from a public health perspective. And all of this is fueled by conservative religious groups. These demands—based on wishfulness—contribute to the increasing bacterial resistance to antibiotics, which in turn is putting the viable segment of our population at risk for unnecessary death from multi-resistant bacteria.

While some might be shocked at the idea of “rationing” antibiotics, or feel that we might head down a slippery slope to euthanasia, I would suggest that consideration be given to the public health aspects of squandering antibiotics on what is widely agreed to be futile care. Is it reasonable to continue antibiotic treatment of such end-stage patients, who have no likelihood of recovery, knowing that they are a breeding ground for multi-resistant organisms that threaten the community? How else might this be addressed? Keep in mind that there are almost no antibiotics in development; many pharmaceutical companies, such as Pfizer, have forsaken antibiotic research as not being adequately profitable. After all, who needs antibiotics when you can have Latisse or Viagra?

Drugs in Search of a Disease

The conclusion in the NY Times op-ed today, “Better Drug Ads, Fewer Side Effects,” raised my hackles a bit. Ian Spatz raises the innocent and  reasonable sounding idea of “legislation that would allow drug companies to cooperate with one another, and with physician and patient organizations, to develop joint ad campaigns that are specific to certain diseases and conditions but not to any particular drug.” While this may be an improvement over the current plethora of erectile dysfunction drug ads, the proposal skirts an important issue.

Spatz optimistically concludes, “Instead, we’d get unbiased information about the medical conditions we care about, and encouragement to seek out the medicines and vaccines that can help us maintain and improve our health.”

Two problems are immediately evident. The first is that the emphasis remains on medicines. While I certainly value drug therapies, we would have a far healthier population if there were a more holistic approach and emphasis on nutrition, exercise, preventive care, and personal responsibility. Instead, patients are encouraged to seek instant gratification for any minor complaint, rather than taking any—let alone difficult—steps to alter their behavior or be an active, responsible participant in their well-being.

Secondly, this fuels disease mongering and the idea of some new drugs being in search of a disease. A fine example of this was the NPR story, "How A Bone Disease Grew To Fit The Prescription," which vividly described osteopenia having been created as a new disease. Not only was there a new need for a drug, but an entire industry rose up around special new x-ray machines, called densitometers, to diagnose osteopenia, and repeated diagnostic tests to monitor therapy. Then the “Bone Measurement Institute”, created by Merck, successfully lobbied Congress to pass the Bone Mass Measurement Act, which required Medicare to cover the costs of the scans. This biography of osteopenia and its multi-billion dollar industry is a must-read. It also makes me wary of the claim that this new model of patient education won’t just be a repeat of the same successful—for pharma—approach.

Note: Clinical research has shown that drugs for osteoporosis are effective are valuable and may be life-saving. Drugs for early osteopenia have not shown such benefit, and have many serious side effects).

This innocent sounding proposal to educate patients about diseases is promising—but only if it is not instead twisted into a tool to create new diseases and lucrative drugs.

Genzyme's Business Model-You've Got to Read This!

An excellent, thought provoking article by Stephen Heuser, "One girl's hope, a nation's dilemma," appeared in the Boston Globe on June 14. Mr. Heuser details the appalling, rapacious approach Genzyme takes to marketing orphan drugs. A guest response, detailing some of the lesser known implications of Genzyme's predatory practices, follows:

"The Boston Globe article about Genzyme’s business tactics is quite alarming.
Nearly every country in Latin America has incorporat ed a legal guarantee to the "right to the highest attainable standard of health" (a.k.a. right to health) in their constitutions. This judicial language has been enforced in a number of countries.

The right to essential medicines is defined by WHO as “those that satisfy the priority health care needs of the population," with the caveat that they “are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford."

Recent court cases, particularly in Brazil (initially surrounding access to ARVs) have increasing granted the right to access to essential medicines in Latin America, insisting that the government provide the drugs, no matter the cost. In the past this has led to successful cost-lowering mechanisms which both made the drugs available and didn't run the health budget completely dry. For instance, Brazil put significant pressure on international pharmaceutical companies to lower the prices on anti-retrovirals by developing the pharmaceutical capacity to produce their own generic forms as well as fighting heavily in the World Trade Organization. They also focused attention on prevention efforts, as a way to curb the number of people who would eventually need the drugs.

However, the same leverage does not necessarily apply to a small country like Costa Rica. The pharmaceutical capacity is probably not there, and it is too small a population for market interest in many circumstances.

But this particualar case raises a interesting and less discussed issue--- are drugs for rare diseases considered essential medicines, and does the government have the responsibility to provide them to any affected citizens, no matter the cost? In some ways the problem is ultimately about the ability of the pharmaceutical country to charge any amount, unrelated to a reasonable assessment of the costs of production and a marginal profit.

The U.S. has dealt with the issue of rare diseases by creating special incentives for companies to develop drugs for these diseases, on the assumption that there will be no market for profits. This has been moderately successful.

But Genzyme, is breaking the rules (at least in a moral sense). They are using very dirty tactics and enormous resources to engage governments in a questionable manner. While the right to health is open to interpretation, I find it hard to justify such enormous expenditures for so few individuals. That being said, it is not inconceivable for the drug to be viewed as essential.

The problem really lies in the fact that the company is charging such an enormous price, with a huge profit margin, and very little threat of competition in the form of generics, and they stay below the public health activists radar to a great degree.

While pharmaceutical companies have the right to make a profit, just like any other corporation, they should not be allowed to intentionally drain the already strapped resources of the Ministries of Health of developing countries."

Heather Stone
Founder, President of G.A.A.P.E.:
Global Action Against Poverty Everywhere!
Smith College

FDA Approves a New Drug for the Annoyingly Cheerful

In one of the best satires I've seen since "That Was the Week That Was," the Women's Bioethics Blog called my attention to the FDA's approval of Pfizer's new drug, Despondex, to cure the Pollyannas among us.



I wonder how sales will compare to Viagra? Stay tuned...

Algeferin Conquers Antibiotic Resistant Bacteria: Too Good to be True?

An intriguing report from Science News touts the discovery of algeferin, a chemical from sponges. Algerferin said to be able to reprogram antibiotic resistant bacteria to make them susceptible to antibiotics again. Preliminary tests against "superbugs" (such as MRSA) and biofilms are said to be very promising.

The potential for treating biofilms, clusters of bacteria that cause serious nosocomial (hospital acquired) infections by adhering to foreign devices, such as IV catheters, is quite intriguing, as such infections are particularly difficult to treat. Especially notable was the statement that biofilms "dissolved when treated with fragments of the algeferin molecule. And new biofilms did not form."

Thus far, algeferin has been tested against a variety of resistant organisms, including MRSA and Pseudomonas. That the chemical can restore bacterial susceptibility to antibiotics would be terrific, if it holds up. We are running out of effective antibiotics, which are often irresponsibly squandered (from bacterial resistance partly due to inappropriate use of these drugs for viral illness and in “animal growth” feed, for example). Resistant bacteria are also spread throughout hospitals and nursing homes by ineffective or sometimes irrational infection control policies, as well as by carelessness and increasingly harried staff.

The promise of algeferin is quite exciting...but based on the history of antibiotic development, misuse, and resistance, I have little doubt the bacteria will outsmart algeferin--or its prescribers-- too.