Fixing the Pharms

Whether you love or loathe pharmaceutical companies, it's clear that we have a problem with pharmaceutical delivery in the U.S.

First of all, some drugs are inexplicably expensive. There's the $93,000 prostrate cancer drug Provenge, for example,  which I've blogged about in the past ("The Skewed Values of Drug Prices"). A more recent example is Anascorp, an orphan drug (used to treat rare diseases) approved by the FDA in August to treat scorpion stings. Anascorp has been used in Mexico for many years, at a cost of $100 per dose, but in the U.S. it now costs  $12,000 per dose, according to a recent Kaiser Health News blog post on the topic ("Treating a Scorpion Sting: $100 in Mexico or $12,000 in U.S."). Blog author Jenny Gold points out that patients need up to five doses of the anti-venom to recover.

It's not fair, however, to blame the cost entirely on the manufacturer, Rare Disease Therapeutics. Gold writes that hospitals in Arizona purchase Anascorp for about $3,700 per dose, then mark up the price to cover their own costs, including the cost of providing care for uninsured patients. It's a long and tangled journey from a $100 dose to a $12,000 dose, and one that does not serve patients well.

More common drugs aren't faring much better, however. There is currently a shortage of generic injectable drugs used to treat cancer and other serious medical problems, an issue covered earlier this month by another Kaiser Health News blog post ("Drug Shortages Affect More Than half a Million Cancer Patients").

The problem has become so acute that it triggered a presidential smackdown, a.k.a. an executive order, in October that demands FDA action and includes Justice Department investigations of possible price gouging.  There are many reasons for these drug shortages, such as a shortage of raw materials needed to make the drugs, and a limited number of manufacturers, who drop production of the drugs if they are not profitable enough or if they have problems with the manufacturing process (as sometimes happens with vaccines).

What's the cure for all this? Don't get sick, silly. But failing that, as we all do from time to time, it seems clear to me that the government needs to flex its muscle with the pharmaceutical companies that bring both great good and great expense to health care.

Taxpayer-funded research should not lead to drugs that taxpayers cannot afford when they need them. The pursuit of blockbuster drugs - those that earn $1 billion or more per year in revenues -  should not undermine the development of less profitable, equally necessary treatments for other diseases. Government incentives and regulations should ensure that a wide range of manufacturers are providing the medications that Americans need.

"Mommy, why is my hot dog bun blue?"

I'm a bit of a food safety zealot, poking cooked meats with thermometers and whisking leftovers into the refrigerator. But it's hard to keep food fresh and safe when you eat outdoors. On the second day of a camping trip last summer, for example, my daughter held up a bun and said "Mommy, why is my hot dog bun blue?" Horrified, I tossed the bun right away, along with a bag of its azure-tinged companions.

One in six Americans will get food poisoning this year, which causes about 3,000 deaths annually and, not surprisingly, spikes in the summer months. The CDC argues that forces such as the centralization of food production and increased consumption of food produced outside the United States make it increasingly difficult to prevent these outbreaks. Currently, Salmonella bacteria are infecting alfalfa and spicy sprouts in the northwestern U.S. and New Jersey, and a strain of E.coli bacteria in vegetables has killed almost 50 people in Germany and other parts of Europe.

It's scary stuff. But even without food contamination that originates in a farm or a factory, Americans do a pretty good job of giving themselves food poisoning on their own. To prevent food poisoning caused by lax food preparation habits at home, the USDA, FDA, CDC, and the Ad Council just launched a consumer ad campaign. Their clever, friendly campaign encourages everyone to keep food preparation areas clean, separate raw meat from other ingredients, cook food to the right temperature, and chill uneaten food adequately.

To remind us all to be careful with food this summer, here's a sample of the ads:

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.

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.

Food and Class in America

I'm interested in the locavore food movement, and agree with the principles of the slow food movement: think about where your food comes from, and how both the food sources and those who grow and pick the food are treated.

Finding, buying, and/or growing the freshest seasonal foods, however, can be both expensive and time-consuming. Because it takes time and money to be a foodie, the locavore and related foodie movements are class movements as well. Newsweek's November 29 cover article, "Divided We Eat," by Lisa Miller, explores the class divisions that food can create.

"Food has become the premier marker of social distinctions, that is to say - social class," epidemiologist Adam Drewnowski told Miller. "It used to be clothing and fashion, but no longer, now that 'luxury' has become affordable and available to all." Since the cost of nutritious food is rising faster than the cost of unhealthy food, wrote Miller, the poor often can't afford to eat healthy food. Wealthier (and subsequently healthier) families can.

It's clear from some of the content in the Newsweek article that some people are far more concerned about the quality of what they eat each day than about what - or whether - others in their community eat. Eating locally, for example, might be both high-status and tasty, but it doesn't solve the fundamental problems of our flawed food system.

The legislation that expands the FDA's powers to inspect food that passed in the Senate this week, on the other hand, might bring about more profound changes. The new legislation would let the FDA recall food, better access records at places where food is produced, increase the frequency of inspections of food facilities, and inspect a wider range of imported foods, explained Lyndsey Layton in the Washington Post ("Senate approves bill to require foodmakers to find ways to prevent contamination").

An overhaul of school lunch funding is also working its way through Congress now. The Healthy, Hunger-Free Kids Act would expand school lunch funding, increase the number of children who are eligible for the program, and encourage using local food sources for the lunches. The act would also encourage schools to create schoolyard gardens.

Class divisions have real consequences on people's lives. Analyses of health and life expectancy by neighborhood, such as one that a local county public health department conducted earlier this year, make it clear that where you can afford to live affects how long and how well you live. Health, wealth, and class are all related. Expanding access to safe and healthy food might help narrow the health gap between different classes, and perhaps budge some class divisions as well.

What Spiked Energy Drinks Say About Us

Canned drinks that contain both alcohol and caffeine have been wreaking havoc among young adults over the past year. These beverages, such as Four Loko and Joose, are a health threat because "caffeine masks the effects of alcohol... tricking users into believing they can keep drinking well past the point of drunkenness," wrote Abby Goodnough and Dan Frosch in a recent New York Times article on the drinks ("F.D.A. Expected to Act on Alcoholic Energy Drinks"). The beverages are popular among young adults because they are inexpensive and they come in energy-drink flavors such as lemon-lime, fruit punch, and watermelon.

This week, the FDA sent warning letters to the manufacturers of these "caffeinated alcoholic beverages", stating that the Agency might seize their products as illegal substances if the manufacturers do not change their formulas. The health consequences from consuming these beverages can include alcohol poisoning, car crashes, and even heart attacks in young drinkers.

A Washington Post article about these beverages pointed out that the young adults who consume them sometimes document their drunken exploits on sites such as fourlokostories.com ("FDA, FTC crack down on caffeinated alcoholic drinks"). The stories there, if they are true, show a wide range of dangerous behavior, including drunk driving and fist fights, and often include the phrase "the last thing I remember...." 

In response, Four Loko manufacturer Phusion Products LLC has (begrudgingly) agreed to remove caffeine from its products. But some manufacturers and many young adults who consume these beverages find the FDA warnings intrusive. "It's time the FDA started treating consumers old enough to purchase alcoholic beverages as adults," Gregory Conko told the Washington Post . Conko represents the libertarian think tank The Competitive Enterprise Institute.

Which raises the question: what makes someone a mature adult? Is it simply being old enough to buy alcohol in a store, at age 21, and hopefully consume it responsibly? Being old enough to vote and join the military, at age 18? Graduating from college? Getting married? Starting a career? Buying a house?

With the start of mature adulthood unclear, it's also unclear how to treat young adults who might, or might not yet be, mature. I would like to trust young adults to avoid or limit the use of dangerous products such as Joose. But I also would like to see these beverages, which clearly target young adults, banned so that they aren't tempted by the wrong choice, while we continue to figure out what it means, exactly, to be a grown-up in this society.

New Cigarette Warnings Don't Solve the Problem

The new, graphic anti-smoking warnings proposed by the FDA should be chosen by the middle of next year, and run on cigarette packets by the end of 2012. The warning images do give you pause, such as the picture of the very ill woman in  "Warning: Cigarettes Causer Cancer" and the man smoking through his tracheotomy in  "Warning: Cigarettes Are Addictive."

The new warnings might indeed further drive down smoking rates in the United States. Tobacco companies, though, have already shifted their strategies to sell cigarettes to promising markets abroad, such as China (where over half of the men smoke, according to 2010 World Health Organization statistics) and India.  

"Cigarette companies are aggressively recruiting new customers in developing nations... to replace those who are quitting or dying in the United States and Europe, where smoking rates have fallen precipitously," wrote Duff Wilson in a New York Times article on international cigarette sales and legislation ("Cigarette Giants in a Global Fight on Tighter Rules"). "Worldwide cigarette sales are rising 2 percent a year," Wilson wrote.

To protect their markets, some cigarette manufacturers work to suppress what they consider excessive anti-smoking legislation abroad. Wilson wrote that when Uruguay tried to limit cigarette use by covering 80% of cigarette packages with health warnings, cigarette manufacturer Philip Morris International, whose sales exceed Uruguay's gross income, sued the country.

Driving cigarettes out of the U.S. market, as the FDA is doing, is really just pushing tobacco into other countries that have fewer resources to resist it. In response, the World Health Organization is fighting global tobacco use with its Tobacco Free Initiative, but it's clearly a tough battle.

Egg Recall Reveals Larger Food Policy Problems

When I read about the recall of eggs shipped here to California, among other states, I printed out the list of the identifying numbers on the recalled cartons and opened my refrigerator. Lo and behold, there were two cartons of recalled eggs that we had purchased recently from the grocery store.

"We should become urban farmers," I told my husband, after he dispatched the eggs down the garbage disposal. At least then we would know where our eggs came from, instead of worrying about tainted eggs shipped from an Iowa mega-farm with a history of safety violations showing up in our West Coast home.

The Washington Post ran a fascinating article this week explaining how cost-cutting consolidation and growth in the egg industry have far outpaced regulation, which lead to the egg recall. "Just 192 large egg companies own about 95 percent of laying hens in this country, down from 2,500 in 1987," wrote the Post's Lyndsey Layton, and most of the eggs come from just five states. Although consolidation has accelerated over the past 20 years, regulation has not. Layton wrote that "the Food and Drug Administration, which has responsibility for the safety of whole eggs, had never inspected the two Iowa-based facilities at the heart of the massive recall that began 10 days ago."

Layton explained that different regulatory agencies divvy up who inspects chickens and who inspects eggs, and that some states do their own egg inspections while others (such as Iowa) do not. These circumstances make it easy for egg inspection to fall through the cracks. New legislation that would require yearly FDA inspections of egg producers is working its way through Congress now.

Unfortunately, legislation doesn't always protect public health. Take agricultural subsidies, for example. In a recent New York Times article about obesity in America, writer Natasha Singer explains that making healthier food cheaper could help Americans eat healthier and lose weight. Government subsidies for the products used in fast foods, though, make them more affordable for consumers than fresh fruits, vegetables, and healthier choices. Singer explains:

The inflation-adjusted price of a McDonald's quarter-pounder with cheese... fell 5.44 percent from 1990 to 2007, according to an article on the economics of child obesity published in the journal Health Affairs. But the inflation-adjusted price of fruit and vegetables, which are not subject to federal largess, rose 17 percent just from 1997 to 2003, the study said. Cutting agricultural subsidies would have a big impact on people's eating habits....

Government policies should support the health and safety needs of the majority of Americans, and we're clearly not there yet, as food recalls increase and healthy food gets more expensive.

Not that everyone has to start a backyard farm; I can't even talk the family into getting a beehive. But I think that we do need to question how our food is produced and where exactly our food comes from and, if necessary, pay more to support food that is healthier and safer until changes in regulations and subsidy policies make that a reality.

Big Bucks and Orphan Drugs

I had the opportunity a while ago to cover a pharmaceutical company’s drug development meeting. The meeting took place at a lovely and incredibly expensive hotel, and the salmon and petit fours for lunch were a far cry from my usual refrigerator-browsing when I work at home. I knew that the pharmaceutical industry was exceedingly wealthy, but I hadn’t seen it up close before.

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.