Monday, November 17, 2008
Is Google Flu Trends just another odd little Google project that their employees tinker with at the Googleplex in Mountain View in between running the search engine and scanning in every book ever written? Apparently not. Google mapped five years' worth of their flu data against flu data from the Centers for Disease Control and Prevention (CDC), which the agency compiles from health care providers, emergency room visit statistics, and other sources. Data from Google correlated closely with CDC data, often predicting flu outbreaks a week or two before the CDC. Google will soon publish a paper on its methodology in an upcoming issue of Nature.
Health care researchers already search for trends in anonymized electronic medical records (EMRs) that some practices use to record patient medical data and prescriptions. More digital data will become available in the future as EMRs become more common (especially since the federal government is providing financial incentives for Medicare providers to adopt e-prescribing, starting in 2009) .
For various reasons, however, many patients are not entirely honest with their doctors about their symptoms and medical concerns, a problem health care providers have struggled with for years. A patient might be embarrassed about a medical problem, forget to mention a symptom, or simply not realize that a symptom is significant. For this reason, search engine data might provide an even larger, and potentially more accurate, data pool than EMRs to indicate the actual incidence of conditions such as pre-diabetes or early heart disease, for example. Public health officials could then use the data to create more effective screening and prevention campaigns.
Friday, October 17, 2008
Almost 60% of those surveyed said that health care is a "major issue" in their upcoming choice for president, according to a recent press release by the organization. Health care is also the top personal concern for men and women, who worry most about the cost of health care. Almost 70% of respondents said that chronic diseases should be diagnosed and treated better in order to control costs.
The Partnership to Fight Chronic Disease states that over 75% of U.S. health care dollars (in both public and private programs) are spent treating chronic diseases. I'm not surprised to read this. I was once told that 10% of Medicare patients have diabetes, but their health care costs take up 25% of the Medicare budget. All told, chronic disease costs eat up about 96% of Medicare's budget and 83% of Medicaid's budget, according to the organization.
At a presentation on aging that I attended last year, the speaker pointed out that medicine has moved from "cure to care" -- in other words, most diseases these days are managed long-term rather than cured with medical or surgical interventions. People are living longer, but not necessarily better, as chronic disease rates have been increasing steadily each year. Today, many experts, such as those affiliated with the Stanford Center on Longevity, are trying to prevent or delay the onset of chronic disease in order to cut medical costs and improve people's quality of life.
Voters seem to understand how the burden of chronic disease affects our health care system. It will be interesting to see how this issue plays out in November.
Monday, September 29, 2008
In response to this trend, the Blue Cross Blue Shield Association has partnered with state governments in Oklahoma and Arizona to develop a health care premium subsidy program for small businesses with 50 or fewer employees, CQ HealthBeat News reported recently. Close to 20% of the population in both states is uninsured, according to the article. Over half of the employees who signed up for the Oklahoma program (called Insure Oklahoma), had been uninsured previously. Advocates of the partnership hope that these subsidies will decrease or eliminate the number of uninsured people in these states, CQ HealthBeat News reported.
Another good idea in today's economy: vegetarianism. A NewScientist.com article in July cited a Cornell University study that showed that if all Americans ate a vegetarian diet (unlikely, I know, but possible), they could reduce the amount of fossil fuel used to produce food by one-third. Producing animal products consumes far more energy than producing plant products for human consumption. Plants such as feed corn must be grown and transported to animals in another field in order for the animals to grow large enough to eat. Then the animals or their dairy products must be processed and transported to the grocery store. Corn meant for human consumption only takes one field and, once harvested and processed, is transported directly to the grocery store.
The health benefits of eating a plant-based or plant-biased diet are well documented. Eating less meat and dairy and more fruits, vegetables, and grains can save money on both energy costs and health expenses. Eating more plant products might not be a radical idea, but it could directly impact the troubled economy.
Tuesday, September 23, 2008
If the poorest Americans are having trouble getting needed medical care, it's time for some intervention. Who's intervening? The pharmaceutical companies. Yesterday's Kaiser Daily Health Policy Report cited an article about this connection in CQ HealthBeat. The Pharmaceutical Research and Manufacturers of America (PhRMA) have given $11.3 million to indirectly support the beleaugered State Children's Health Insurance Program (SCHIP), a program targeted to children in low-income households and administered by the Centers for Medicare & Medicaid Services (CMS). The PhRMA money will help fund advertisements by a SCHIP advocacy group in support of a SCHIP expansion bill vetoed by President Bush (HR 3963), Kaiser reported.
Insuring more poor children is ethicially sound. Not coincidentally, it will also boost sagging pharmaceutical industry profits if these children receive needed medication for asthma, diabetes, and other illnesses.
Sunday, August 31, 2008
It was my first real business trip, and I was thrilled to travel on someone else's dime. I had bought a travel guidebook, hoping to haul my co-workers out to eat beignets and crawfish and bread pudding with bourbon sauce in the French Quarter. Could we squeeze in a garden tour or a paddleboat ride up the Mississippi or a jazz club or (one co-worker's favorite) a swamp tour that promised alligator spottings, I wondered? No -- I had to work. We slogged onto the shuttle to the convention center each morning, and took turns running the booth where we were selling patient education brochures.
Clearly, New Orleans was poor. The air-conditioned ride from the hotel next to the French Quarter to the enormous convention center was probably walkable, but I doubt the visitor's bureau wanted conventioneers to look closely at the tiny run-down houses, sketchy-looking bars and restaurants, and broken pavement that reminded me of the south side of Chicago. I knew the crime rate was high, too. Still, I loved New Orleans because it was so different from where I lived: the music, the southern accents, the humidity, the alligators, the fried food for breakfast, lunch, and dinner. When I got back, I told my husband that we needed to take a vacation there some day.
Then Katrina hit. I spent a week glued to the television every night, yelling variations on why the doesn't somebody help these people? I held my own infant daughter as I watched parents pass a baby in diapers onto a bus that they couldn't get on themselves to escape the flooded city. The television showed images of bodies floating face-down in the water, of a young woman going into a diabetic seizure after yelling "I don't want to die!" in the convention center where I had been. Each day that people were still stuck in the city, I became more incredulous and horrified.
The memories return to me, unwanted, with Hurricane Gustav currently headed for New Orleans, even though New Orleans is almost fully evacuated now and far better prepared for a hurricane than it was before Katrina. I told my husband Katrina was the worst thing I ever saw on television. There was nothing to do but watch the misery unfold, and watch the places I had been become utterly unrecognizable.
Thursday, August 28, 2008
The authors track the self-reported health status of married and unmarried men and women over three decades. In 1972, women who were married, divorced, widowed, or never married all had about the same rate of excellent/good health (a probability of about .92), while separated women had lower rates of excellent/good health (a probability of about .9). Married men in 1972 were more likely to report excellent/good health (about .92 probability) than those who were widowed, separated, or divorced (about .91 probability). Never-married men were least likely to report good/excellent health (about .89 probability). By 2003, however, the dissolution of a marriage had become a health liability for both genders. Men and women who went through separation, divorce, or the death of a spouse had the worst health, the authors write.
Over the years, unmarried men have become about as healthy as married men, in contrast to the 1972 statistics. The authors attribute this increase to better social support for single men, although they point out that there are many other ways to interpret this data, such as improvements in medical care since the 1970s. Widowed people in 2003, especially women, had far worse health than married men and women. Ultimately, the authors find marriage a risky proposition these days because so many marriages fail. They conclude that "getting married increases one's risk for eventual marital dissolution, and marital dissolution seems to be worse for self-rated health now than at any point in the past three decades."
Why is post-marriage life so dismal for both men and women? Studies have shown that marriage provides economic benefits and social support, both of which can positively impact a person's mental and physical health, the authors write. If a married couple is deeply unhappy, however, separation or divorce seems like a solution that will ultimately make each partner happier and healthier. The authors point out that the couple pays the price, though, in the increased economic strain of maintaining separate households. If a partner has been out of the workforce for a while the economic blow is even worse, and can harm their health even more.
Thursday, July 31, 2008
Google's HealthMap provides a visual compilation of a range of diseases reported in the past 30 days from various sources, and in the U.S. salmonella tops the list. The most recent Salmonella saintpaul outbreak, initially blamed on tainted tomatoes, began in April and was finally traced to a pepper farm in Mexico on July 30, according to an article in the Washington Post. Over 1,300 people contracted Salmonella saintpaul this summer, the article stated.
Earlier this month, the center for Science in the Public Interest called for a better labeling process to track where each piece of produce originates, in order to quickly find the source of tainted foods. Growers fought against more stringent produce labeling for years, but they also lost more than $100 million in revenues when tomatoes were mistakenly blamed for the most recent outbreak.
Just to be safe, I've avoided raw tomatoes all summer. I usually use raw tomatoes year-round, and rarely stop to think about whether they are in season, or where they come from. Chile? Guam? Who knows? All I know is that I need tomatoes for a recipe I'm making. But I'm rethinking my blindness to the seasons, and the price (energy consumption, possible difficult-to-trace foodborne illness) of eating food grown so far away. How many trucks, ships, and airplanes has this produce been on, before it is presented (and misrepresented) to me as if I had pulled off a country road to buy fresh fruit at a farmstand? Lately I've started going to my local farmers' markets for produce, where the path from farm to fork is shorter and far less deceptive.
Thursday, July 24, 2008
Although I work online almost every day, I barely touched anything with a silicon chip in it until I was in college, when PCs were just catching on. When I was ten, I borrowed my parents’ old typewriter to write short stories for fun. I remember that the keys would cross and jam if I typed too fast. Sometime I’d land my hands back on the keyboard wrong after I pushed the carriage return, and type a line of gibberish before I realized what I’d done.
As someone who remembers the drudgery of using carbon paper and correction fluid and smudgy typewriter ribbons at her first office job, I’m all in favor of technological advances. But making things easier can create fresh problems, and as manual and electric typewriters faded away, repetitive strain injuries such as carpal tunnel syndrome began to rise. With a typewriter, you have many built-in breaks for your hands, such as pushing the carriage return or feeding in a fresh sheet of paper. Without any electronic boost, manual typewriter keys also require a fair amount of pressure just to work. All this slows down your typing speed, but it doesn’t hurt your hands.
Today’s keyboards and devices encourage a light touch and micro-movements of the hands and wrist, with minimal breaks. This hardware irritates the nerves, tendons, and muscles in the hands and arms, creating new medical problems such as "Blackberry thumb."
The hardware manufacturers generally seem uninterested in the injuries their devices have caused. Dell Computer, for example, the largest desktop and laptop manufacturer in the world, ships standard PCs with an ergonomically-unwise flat keyboard and mouse. They do provide a handy one-page description of how to set up your desktop computer on their website, but users who want to prevent a repetitive strain injury need to pay extra for break software and ergonomic tools.
Instead of repetitive strain injury prevention, the technology industry has focused on increasing revenues by adding lots of (often unnecessary) features to devices and by shrinking the footprint of silicon chips as much as possible. Smaller chips lower chip manufacturing costs and ultimately technology device costs, and help manufacturers shrink devices to make them lighter and more portable. Not surprisingly, lighter, smaller, cheaper, feature-rich devices are more attractive to customers.
Enter Apple Computer, whose forthcoming MacBook laptop is rumored to have an iPhone-like touch screen user interface. It sounds cool, and probably will sell like hotcakes, but it also sounds like a fresh source of injuries. Using a touch screen, presumably touching the screen lightly with just one or two fingers, is hardly the same experience as pecking away at a typewriter.
Monday, June 30, 2008
When I pick up the phone, the friendly woman's voice greets me in Russian. Or maybe it's Romanian? Or Polish? Then she begins a long discussion about an upcoming medical appointment in the mystery language. I know this because she mentions my name and a local medical center in English. She calls about once a month, a glitch in some health care provider's electronic appointment reminder system.
Ah, medical information technology. I still can't decide whether I like it or not. At my daughter's pediatrician's office, I wonder why they're still using a giant, scribbled-over paper appointment book and paper folders to hold medical records. Then I remember that a shift to appointment scheduling software and electronic medical records could mean technology glitches like my periodic Russian phone calls and the imposition of a laptop screen between the doctor and me when we talked. On the other hand, I reason, it's incredibly useful when a doctor I'm visiting can pull up electronic test results from another doctor I saw recently. Yet this easy access is also creepily Orwellian. How many people, exactly, do have access to my medical information? And what are they doing with it?
Sometimes, medical IT practices can cause real harm. A recent article in JAMA analyzed how radio frequency identification (RFID) devices, used to identify patients and equipment, can also interfere with medical equipment used to treat and manage medical problems. My daughter and I received RFID wristbands when she was born, in order to make sure that no unauthorized person took her from the hospital. Could the wristbands’ signals have interfered with the lifesaving equipment used on the infants in the neonatal ICU down the hall? Possibly, according to JAMA.
As I sort through my own opinions about information technology and medicine, the technology marches forward relentlessly. At the moment, the Markle Foundation, a public/private collaborative studying IT, health, and national security issues and endorsed by WebMD, the
Saturday, June 28, 2008
The public health cost of ART preterm births was approximately $1 billion in 2005, or an average of $51,600 per infant, the report stated. One percent of all
Addendum - July 17, 2008
Thursday, May 29, 2008
Perhaps unwisely, I added it all up: six medical appointments in April (one of them for a child), and nine in May (one for a child). Some were mercifully clustered around a medical campus in the north part of city, some in the south part of the city, and two were east or west of the medical campus. Some providers collected co-pays on the spot, and others sent a big fat bill later on ("What's this?" my husband asked, waving an itemized list of co-pays in the air recently). To complicate things further, my insurance company periodically sent me bills for provider visits recommended by my PCP that they only covered partially.
My experience was typical, according to a poll of women's views of health care released today by the American Academy of Family Physicians (AAFP). The Harris Interactive poll of 1,270 women, commissioned by the AAFP, found that cost and time constraints were the top challenges women faced in obtaining health care for themselves and their families (in San Francisco, I would add "parking"). The AAFP used the poll's data to advocate for a medical home model, where all medical care is coordinated through a primary care physician and streamlined through technology such as electronic medical records, e-prescribing, and emails between patients and providers.
Considering the number of uninsured Americans, I'm supposed to write that I'm grateful to have decent medical insurance -- which I am, of course. I'm also grateful, however, for the new clients I gained in May, whose work, out of necessity, took up many nights and weekends this month as I juggled interesting new assignments with a relentless march of medical appointments. I'm equally grateful, as these appointments wind down at last, that I'm not coping with a chronic condition that requires frequent provider visits, and co-pays or bills for visits, prescriptions, or durable medical equipment.
At the end of May now, I have finished my assignments and met my target number of work hours, although I spent less time than I wanted to with my children. Luckily, I managed to squeeze in a weekday off to play hooky with my older daughter recently, who had a rough month at school. We both needed the break.
Thursday, May 8, 2008
Technical and medical advances have greatly improved survival rates for soldiers injured on the battlefield, but as a result there are more seriously injured veterans to treat within the VA system, according to Government Executive.com. A RAND Corporation study estimates that about 300,000 returning Iraq and Afghanistan soldiers have post-traumatic stress disorder (only half receive treatment for PTSD), and 320,000 have a traumatic brain injury.
I remember that in 2006, the VA was widely praised as a model health care system. In fact, I assigned a story on this very topic to a freelance writer I worked with. The VA boasted an efficient, timesaving electronic medical record (EMR) system, geographically widespread facilities, access to and support of new medical treatments and techniques, and lower prescription drug costs than many private health plans due to bulk drug purchases. The VA has been considered a possible model for a nationwide universal health care plan.
Its image has been tarnished more recently, with the mismanagement and neglect at Walter Reed Army Medical Center reported by the Washington Post in 2007, for example. There is currently a class-action lawsuit against the VA in
The fundamental problem is limited funding, which threatens the VA every year. This problem will only get worse as soldiers continue to return home with complex and expensive mental and physical health problems. The suicide rate is a stark reminder that the VA has failed to help these people.
Wednesday, April 30, 2008
One important difference between all these vaccines is that Gardasil is given before any cancer diagnosis, and the other vaccines under trial that I mentioned are given after a cancer diagnosis in addition to standard cancer treatment. These post-diagnosis vaccines seem to be the trend with cancer vaccines, despite the heavy marketing of Gardasil. These vaccines are designed to "retrain" the patient's immune system to respond more effectively to proteins associated with cancer cells. Some of these vaccines are developed using the patient's own cells, and other are not.
Two promising post-diagnosis vaccines under investigation that are not gender-specific target lung cancer (the most deadly cancer among both men and women) and cutaneous melanoma (which is more deadly among men than among women).
I'm curious about the gender differences between cancer vaccines. Do women respond more favorably than men to cancer vaccines, or vice versa? Are vaccines that use the patient's own cells more or less effective than those that don't? Are vaccines for gender-specific cancers, such as prostate and cervical cancer, more or less effective than vaccines for cancers that can strike both genders? There might be no patterns here, but if there are, it would be interesting to see how physiology, sociology, and other factors impact the effectiveness of these vaccines.
Wednesday, April 16, 2008
Although BPA is also sometimes found in tableware, medical devices, dental sealants, and automobiles, among other places, the draft brief stated that humans primarily absorb BPA though food and drink. The
The draft brief points out that most ingested BPA is metabolized and eliminated in the urine. The remaining ("free") BPA in the body is probably harmful. Based on evidence from animal studies, infants and young children are thought to be less efficient at metabolizing and excreting BPA than adults, the draft brief states, so they retain higher levels of free BPA in their bodies. The draft brief also says that BPA seems to leach more easily from plastic into foods when the food is heated. As such, baby bottles (often heated up, of course, before given to the baby) seem like an especially potent source of exposure in infants.
Formula-fed infants aged 0 to 6 months, who are exposed to BPA primarily though baby bottles but also through the packaging of formula containers, might absorb about ten times the amount of BPA as a breast-fed infant, according to the draft brief.
I find this information, and the pervasiveness of BPA in the environment, disturbing news. I first read about the NTP draft brief in a story on the Washington Post online, and the writer considered the report's findings worrisome. A number of other online news outlets, such as Fox Business, on the other hand, chose to run the press release on BPA from the American Chemistry Council as an article. The American Chemistry Council press release, not surprisingly, states that the NTP draft brief proves that there are no serious human reproduction concerns about BPA.
Yes, the data is based primarily on animal rather than human studies, and the authors of the NTP draft brief pointed out a number of limitations to the studies they looked at, such the reproducibility and structure of some studies. I still think that the information in the NTP draft brief is too important to be dismissed – especially for parents, who have been concerned about the plastics in baby bottles for years.
Monday, March 31, 2008
Despite these warnings, the popular and expensive La Petite Baleen program in the Bay Area, which often boasts a waitlist to get into classes, begins training children to be submerged in the water when they are just two months old. A new La Petite Baleen site is slated to open in June in the Presidio in San Francisco, and there are already 1,000 children enrolled, the article stated.
New parents are marketed to relentlessly. I still remember the box of formula that the postman shoved through my gate when I was pregnant with my first child (a product that I didn't want or need), and the mailings I received from Gerber and other companies who knew my due date, probably because my doctor's office had sold them the information. I heard a constant drumbeat of advice and buying information as a new parent, some of it from valid sources and some not.
I succumbed to the marketing as well, I think. Did I buy a Britax car seat and a Hanna Andersson jacket for my daughter because they were the best items on the market, or because being able to afford these things was a marker of my social class as a parent? I probably made these purchases for both reasons. Similarly, I think that the popularity of infant swim classes also has an element of status in it.
Are parents enrolling their young children in La Petite Baleen classes because they think that the AAP is wrong and swim lessons are good for infants and toddlers? Perhaps. Equally compelling, I think, is the social status that attending the school confers to the parents, which trumps anything the AAP says.
Tuesday, March 18, 2008
In the press room, I picked up a book the AAOS had put together describing the artwork, and I paged through it in my few quiet moments. By the end of the week, I had passed by the large bridge-shaped sculpture “Bone Rainbow” many times, although I did not initially notice that the bridge’s crossbars were made of bronze femurs. The artist, Ruth Cozen Snyder, had been injured in a car accident, and said in her artist’s statement that creating art had helped her cope with and recover from her injuries. Much of the patient art I saw and read about tried to make sense of, and rise above, the pain and disability that many patients faced.
My favorite piece was a painting by an orthopoaedic surgeon, called “Nothing About You Without You.” In the painting, a patient with a cast on his right foot and a sombrero hiding his face straddles a chair next to a vivid orange wall, the colors and clothing reminiscent of Central or
The Journal of the American Medical Association always features artwork on its cover, as an antidote perhaps to the technical articles inside. At the AAOS conference, it was refreshing to see such striking artwork as I ducked in and out of PowerPoint presentations featuring sutured knees, diseased hips, and MRSA infection statistics. It was a reminder that there are human beings on either side of the scalpel.
Thursday, February 28, 2008
If employers no longer need to purchase private health insurance for employees, they might need to pay into a local, state, or national health care plan fund. If the plan (either government-based or private) is structured and administered well, with a reasonable level of services for patients and reasonable reimbursement rates for providers, it can provide better care at a lower cost than the patchwork of plans currently available. The debate about the cost of such a plan is raging in San Francisco now, though, with the city mandating employers to pay into a fund that would cover uninsured adults. The Golden Gate Restaurant Association fought the plan, claiming the mandated costs are higher than restaurant owners can afford.
If employer-provided health care is decreased or goes away completely, I think that there will be some unintended consequences for large companies in particular. Many people hold on to jobs they don't like at larger employers solely for the access they provide to quality health insurance. If other affordable, high-quality options become available, I think that these employees will leave their employers. Some will move to work in different fields, but others will move to competing companies, or start their own businesses to compete with their former employer.
According to the White House, small businesses are the engine of job creation in this economy, providing two out of every three new jobs, although the nonpartisan National Bureau of Economic Research questions these rosy statistics. Small businesses freed from the burden of taking on large health care costs once they reach a certain size, however, are likely to grow rapidly. As some larger businesses lose employees and smaller businesses gain them, will the revenue gap between the two types of businesses decrease? Will that change ultimately decrease the gap between rich and poor, and shore up the middle class again?
Wednesday, February 13, 2008
I've been thinking a lot about the
A small but influential 1998 study suggesting a link between thimerosol and autism was later retracted by its authors, and researchers have since found no link between vaccinations and autism. Furthermore, thimerosol was dropped as a preservative in standard vaccines in the U.S. in 2001.
Some parents still refuse vaccinations for their children, though, due to concerns about vaccine contents and the possibility of rare complications. Their choices have lead to regional, sometimes fatal outbreaks of measles and whooping cough (pertussis) among unvaccinated children. Right now, for example, there is a measles outbreak in San Diego, with ten unvaccinated children and infants infected and over fifty quarantined.
The AAP only fueled the vaccination debate, however, with an emotional press release in late January, calling the “Eli Stone” pilot “the height of reckless irresponsibility.” In the letter, AAP President Dr. Renee R. Jenkins says that “if parents watch this program and choose to deny their children immunizations, ABC will share in the responsibility for the suffering and deaths that occur as a result. The consequences of a decline in immunization rates could be devastating to the health of our nation’s children.” The AAP went on to authorize the early release of a February Pediatrics journal article showing that infants expel the type of mercury used in thimerosol over ten times faster than they expel the type of mercury often found in fish. Some researchers believe that if heavy metals such as mercury build up in the body, they might cause autism.
But what this debate really comes down to is parents’ fear of autism, a fear that is especially acute in the San Francisco Bay Area where I live. A CDC study released in 2007 that looked at autism spectrum disorders in selected regions of the country found an average rate of autism of about 1 in every 150 eight-year-old children. Earlier estimates had suggested autism was much less prevalent, as low as 1 in 500 children. The CDC pointed out that it’s unclear whether the autism rates are increasing over time, or whether it is simply being diagnosed and reported more accurately.
Still, no one knows what causes autism, and a quick glance at the numbers makes it look like an epidemic. When I had my first child, I, too, was told by well-meaning acquaintances that mercury-laden vaccinations might cause autism, one of a long list of things to panic about as a sleep-deprived new Mom. If I had my child vaccinated and she developed autism soon thereafter, would it be my fault if the light in her mind dimmed? Was I willing to take that chance?
By the time my children were born, though, thimerosol had been pulled from the vaccines, and pertussis was making an alarming comeback in
There is a frightening childhood illness for every generation, it seems. At one time it was polio, until Jonas Salk developed an effective vaccine for it in the 1950s. My great aunt had polio as a young woman (luckily she recovered fully). My mother, who grew up in the Bay Area, remembers driving by San Francisco’s Shriner’s Children’s Hospital on 19th Avenue with her family, where many of the young polio patients were dependent on iron lung machines, wondering if that would happen to her. Today, the old Shriner’s Hospital is a retirement community next to a row of modern townhouses, and thanks to the vaccine polio is almost completely eradicated worldwide.
Friday, January 25, 2008
The people at the meeting included deferential twenty-something sales representatives and assistants; opinionated mid-career researchers and doctors, who occasionally cracked incomprehensible jokes involving biochemical formulas; and a polite and self-deprecating high-level executive. I’m sure there were plenty of office politics and power plays behind the scenes, but as an observer what I saw was a well-oiled machine. The real politics were external: a corporation versus the FDA (“the Agency,” they called it). The pharmaceutical company was starting human trials of a new drug that they hoped to bring to market if all went well.
For all the people at the meeting, and the expense and effort of bringing everyone together (many from out of town), the new drug was not a potential blockbuster. It was an orphan drug. Orphan drugs are developed to treat rare (orphan) diseases, defined as: diseases that affect 200,000 or fewer Americans, and/or diseases that are uncommon in the developed world (although they may be common elsewhere).
In the past, orphan drugs were too unprofitable for pharmaceutical companies to develop. In 1983, however, the federal government passed the Orphan Drug Act (ODA) to provide tax incentives, research grant money, and marketing benefits to companies that develop orphan drugs. The ODA has had a huge impact on orphan drug development. According to the FDA, from 1973 to 1983, about one orphan drug was brought to market per year. Since 1983, about 250 orphan drugs and products have been brought to market – averaging about ten each year.
The drug in question at the pharmaceutical meeting was designed to replace the current drug treatment, which has several miserable side effects that inhibit patient compliance, for a disease so rare that there might be more people involved in developing and regulating this new drug than there are potential patients for it. But if it survives the trials and the FDA and is brought to market, the drug could vastly improve the quality of life of these patients. It was good to see such altruism from a pharmaceutical company, even if it was prompted by a big carrot from the federal government.