Goodbye, Firehouses

Many years ago, a neighborhood firehouse in San Francisco was quietly converted to a battered women's shelter. If you have to take a firehouse out of commission, at least turning it into a shelter keeps the building's function in the realm of public service. But that type of firehouse conversion is not the norm here. I was dismayed to read a profile in the San Francisco Chronicle today of a converted firehouse in San Francisco that has been recently renovated into two multi-million-dollar townhouses.

Real estate in the Bay Area has become much more valuable over the past few decades, while California's Proposition 13, passed in 1978, continues to limit the amount of property taxes that can be collected from these properties. Property taxes help pay for emergency services, among other things, and without adequate funds, many smaller fire stations have closed - and often renovated into luxury properties. Currently, 51 fire stations in San Francisco serve a population of roughly 815,000 people.

San Francisco was destroyed by the earthquake and subsequent fire of 1906, and the fire did far more damage than the earthquake. Fire returned after 1989's Loma Prieta earthquake, fueled by a broken gas line, destroying parts of San Francisco's Marina District. This video compilation from the San Francisco Chronicle shows some of the extensive damage caused by the 1989 earthquake, such as the partial collapse of the Bay Bridge:

There is no large earthquake here without a fire, it seems, and many people wonder how well the fire department could handle another earthquake. To help bridge this gap, the San Francisco Fire Department now trains citizen groups in basic disaster skills, including rescue and disaster medicine. Because if you need fire fighters or paramedics, it's no use banging on the door of a townhouse that contains a fire station's original fire pole but cannot help anyone in need.

Drug Shortages: Blame Policies, Not Agencies

A recent article in the Washington Post by Rob Stein pointed out shortages of 211 medications in 2010, including lifesaving drugs used in emergency rooms and oncology wards ("Shortages of key drugs endanger patients"). What is causing this shortage? "Experts cite a confluence of factors," writes Stein:

Consolidation in the pharmaceutical industry has left only a few manufacturers for many older, less profitable products, meaning that when raw material runs short, equipment breaks down or government regulators crack down, the snags can quickly spiral into shortages.

Stein points out that there are especially acute shortages of generic medications (which aren't very profitable for manufacturers), especially sterile injectable medications (whose manufacturing processes are complicated and error-prone). There are also shortages of raw materials (often imported from abroad).

Stein cites the shortage of the leukemia and lymphoma drug cytarabine due to problems obtaining raw materials and manufacturing the drug. Cytarabine is a vital cancer drug that many hospitals have been forced to ration to patients. Inadequate medication substitutions have also lead to patient deaths, he said.

It's easy to blame the FDA for some of the problems with the drug supply. As Stein explains, "some industry representatives blame part of the problem on increased oversight by the FDA, which has made drug safety a higher priority after coming under intense criticism for being too lax." If the FDA would just skip a few manufacturing facility inspections, the supply pipeline would be smoother?

Drug supply problems don't originate with the FDA, however. Pharmaceutical manufacturers, eager to turn a healthy profit for their investors, would rather chase the next blockbuster drug (earning $1 billion or more in profits yearly) than thanklessly churn out low-profit items such as generic drugs and vaccines. Increasingly, venture capital firms that might fund new drug development would rather fund profitable new technologies than invest in better treatments for diseases.

The financial market, while it plays a role in drug development, should not drive public health decisions. The antidote to this problem is thoughtful legislation. Laws such as the Orphan Drug Act, which I've written about before, have successfully helped pharmaceutical companies refocus some of their energies on patient needs rather than profits.

Maybe the FDA could require that a company whose FDA-approved drug reached blockbuster status must ramp up its generic manufacturing to a certain level - building more manufacturing plants for a needed drug, or adding a popular vaccine to its roster -  before any more drugs are approved. Why not? Stronger regulations and incentives can encourage pharmaceutical manufacturers to diversify their assets and create a safer and more stable supply of drugs for everyone who might need them some day. 

Meningitis Vaccine Extended to Infants

I'm off to the ASJA Conference this week to moderate a panel on using widgets to maximize your blog (ahem, see the widget on the right for a link to the conference info). But this week's food for thought is the menigococcal disease vaccine Menactra, generally given to tweens and teens (and sometimes to at-risk children as young as 2), which the FDA just approved for children as young as 9 months old.

Will parents get the two-dose vaccine to help prevent bacterial meningitis in their young children - a rare but frightening disease that progresses so fast that it can outrun antibiotics? Or will they turn down the vaccine because there are already so many other vaccines on the CDC schedule for children under 2 years old? I'm wondering how this will play out.

Why it Matters How VCs Spend Their Money

In the biotechnology sector, when non-profit and government organizations can't or don't provide funding, venture capital firms (VCs) often do. The for-profit VCs, of course, want a good return on their investment -- first through promising clinical trials that lead to FDA approval for a product, then through wide and profitable adoption of the product by patients and their health care providers.

But because this process can take a decade or even longer, many VCs are putting their investment dollars into other projects with a quicker payout, particularly social networking, according to a recent Fierce Biotech post by John Carroll that cites a Reuters survey on the topic ("VCs: Chill sets in on biotech as social networking gets hot"). "Why invest in biotech companies which face years of risky clinical trial work," writes Carroll, "when you can grab a stake in a social networking company and potentially cash out in a year or two?"

This investment fickleness is one reason why we need government agencies like the NIH to fund promising research. But we also need VCs, because they have the deep pockets and the business expertise to bring needed health products to market, as long as their investors are willing to make long-term investments.Venture capital-funded companies are developing new vaccines, pain medications, gene therapies, and cancer treatments, to name just a few products.

Venture capital firms invested $5.9 billion in the first quarter of this year, and $784 million of that went to biotechnology, according to the MoneyTree (tm) Report created by PricewaterhouseCoopers, the National Venture Capital Association (NVCA), and Thomson Reuters. The software industry ($1.1 billion) and "Internet-specific companies" such as social networking sites ($1.2 billion) received the biggest pieces of the VC pie in the past quarter, according to an April 15 press release from the NVCA.

Venture capital firms invested more money in biotechnology over the past quarter than in the last quarter of 2010. But the NVCA press release stated that the money is divvied up among far fewer biotechnology companies now than in the past. This means that VCs are funding a smaller range of potential therapies.

It's hard to predict which therapies will succeed, but we need better treatments for widespread problems such as cancer and chronic pain. Ultimately we all benefit when VCs patiently fund the greatest possible number of promising therapies, instead of diverting funds to look for the next FaceBook.

RFID tags in Medicine

Radio frequency identification (RFID) tags can track people, equipment, and paperwork in a variety of settings. They are currently used to track objects ranging from military equipment and nuclear materials to more mundane retail merchandise. These chips are either passive, transmitting a signal only when an electronic device requests information, or active, constantly transmitting a readable signal.

RFID tags are gaining traction in medicine. Surgeons can use "smart" sponges embedded with RFID tags in the operating room, for example. Separate devices can electronically count the number of sponges used and scan the surgical site to make sure none are left in the body, where they can cause pain, infections, and other problems. RFID-embedded identification bracelets placed on infants in maternity wards and linked to alarms prevent unauthorized people from taking the infants from the area.

Outside the hospital wards, RFID-tagged pharmaceutical containers make it easier for the FDA to track the drugs' movement (especially the movement of controlled substances such as the pain reliever OxyContin) and to verify that the drugs are not counterfeit. Some paper medical records have been RFID-tagged to help health care workers find misplaced files.

The Affordable Care Act encourages the use of technology such as electronic medical records and RFID tags to improve medical care and (not coincidentally) to stretch health care dollars by decreasing administrative costs and other expenses. Technology like RFID chips, which can prevent expensive and damaging human errors, should remain just one tool used by health care providers, and does not relieve them of their responsibility to provide the best care they can. Tools can help them with data collection and analysis, but empathy, observation, and insight remain distinctly human, and necessary for good health care as well.

The Skewed Values of Drug Prices

The eye-popping pricing strategies for two pharmaceuticals have been big news lately. First, the cost of a weekly progesterone injection, designed to prevent premature births in at-risk pregnant women, jumped from about $20 per shot to $1,500 per shot.

What happened? The active ingredient of the shot had been compounded by pharmacies as needed by physician request to prevent premature births in the past, while the FDA quietly looked the other way. But in February, the FDA officially approved KV Pharmaceutical's version of the shot, Makena, and KV Pharmaceutical decided to raise the price - a lot.

It was a stunning move for a product whose development was partially funded by taxpayers through the National Institutes of Health, and whose approval had been fast-tracked and supported by the FDA's Orphan Drug Act, according to a recent FDA statement. In response to public outcry, KV Pharmaceutical later dropped the price to $690 per dose. 

Then, on March 30, Medicare announced (in a preliminary decision still in the comment phase) that it would cover the $93,000 price tag of Dendron Corporation's prostate cancer vaccine Provenge, which extends life for a few months in cancer patients.

Dendron's website currently runs an ad for Provenge called "Jonathan's story." In the ad, the patient says "fighting my cancer could mean meeting my new granddaughter, who is due in a few months."  But ironically, current health care policy pits infant health against health care for the elderly.

Is it wise to pay for medication that could extend a long life a few months longer, while allowing companies to create financial barriers to accessing medicine that could help an infant get a healthy start on life? It isn't if you look at health care as a tool to extend healthy years of life, a view that is currently shifting kidney allocation rules, as I've blogged before. In an opinion piece in the Washington Post this weekend, a prostate cancer survivor points out a similar resource allocation problem with Provenge:

One thing I can assure you is that I would never ask Medicare to pay $93,000 for a treatment to extend my life four months. However, I would ask Medicare officials this: if Provenge is prescribed to me as a possible treatment and I turn it down, could I put the savings into a college fund trust account for my grandchildren? I feel the country would benefit much more from educating three of its citizens than from keeping me around another four months. I have a hunch Medicare's answer would be no. 

We need to ask what society owes to two vulnerable populations - pregnant young women at risk of preterm delivery, and terminally ill older men. Rather than pittting ACOG against the AARP, we should step back and ask what is a reasonable amount of funds to invest in protecting each of these populations. And what is a fair and ethical price to charge for the medications they need?