Tough criticisms rise as biotech matures
Lawmakers point to high drug prices, crop worries
Thirty years ago, the business of biotechnology amounted to a handful of scientists, a few brave investors, and a bold, if unproven, idea: By tweaking genes in a lab, you could transform the process of making drugs.
Today, biotech encompasses hundreds of companies around the world and is a marquee industry in New England, where political leaders gush over its ability to create jobs and draw investment dollars to Massachusetts.
But even as biotech revels in its successes, the business is facing a new challenge: criticism for its real-world effect on healthcare spending and agriculture. In particular, congressional Democrats, insurance companies, and some large employers have begun to push publicly against the high price of biotech drugs, which often cost $20,000 a year or more per patient.
The resistance is a new and unwelcome development for an industry that has attracted money and good will by telling the story of its potential. With more than 20,000 people in Boston this week for the BIO International Convention, biotech leaders are crafting a carefully honed message to help fend off critics: Biotechnology, they argue, is still a business defined by its promise. They urge patience now in return for big payoffs later.
James C. Greenwood, the former Pennsylvania Republican congressman who joined BIO as its top lobbyist in 2005, said the mere threat of price controls on biotech drugs would discourage new investors.
"If these biologics companies are going to provide to society the incredible promise they hold," Greenwood said last week, "it's going to take a lot of private investment."
To reinforce the message of incredible promise, press conferences and seminars this week highlight biotechnology as a solution not only to health problems, but also to global energy and environmental woes.
But behind the industry -- and the reason the convention has grown to more than 20,000 people, with 300 off-site parties and other events throughout the city -- are dozens of biotech products that have already progressed well beyond potential. By far, the most profitable are high-priced injectable drugs. One, Aranesp, has sales of more than $4 billion a year. And numerous biotechnology drugs, including those made by
Profits have also brought unwelcome attention from Washington and the insurance industry. Congress is seeing a strong push to lower the price of biotech drugs by allowing generic versions to be approved. Insurers and employers, too, are starting to take a hard look at biotech spending, which mounts every year.
Estimates are difficult because there is more than one definition of a biotech product. But specialized injectable drugs -- a category roughly synonymous with biotech drugs -- accounted for $54 billion of healthcare spending in the United States last year, according to the pharmaceutical-benefits manager
Another analysis, by life sciences accounting giant Ernst & Young, showed biotech companies around the world had $70 billion in sales in 2006.
Less profitable, but far more widespread, is the use of biotechnology in agriculture. By tweaking genes of corn, soybeans, and other well-known crops, bioengineers have created higher-yield versions of long-time staples of the food supply.
Crop bioengineering has long drawn the ire of protesters who believe that sterile, high-yield engineered crops represent a violation of years of natural plant evolution and breeding. Protests against genetically modified organisms, or GMOs, are common at biotechnology conventions, which draw "teach-ins" and inventive protest posters that depict a fertile world under assault from the chemically powered forces of industry.
"The technology of genetic engineering is inherently uncertain," said Brian Tokar of the Institute for Social Ecology , a co-organizer of this week's BIO protests. "We also know there's a threat of environmental contamination and contamination of other crops. And farmers all over the world are concerned about the increasing concentration of corporate control over seeds."
Most likely, that battle is already lost. Although some biotech foods, such as the Flavr Savr tomato, failed as commercial products, the Biotechnology Industry Organization estimates that 60 percent of corn and nearly 90 percent of the soybeans grown in the United States are bioengineered strains.
But other battles are just beginning. In Washington, Democratic Representative Henry Waxman of California and Senators Hillary Clinton and Charles Schumer of New York , also Democrats, have introduced a bill to allow generic biological drugs. Because there is currently no way to get such drugs approved without running full human clinical tests, generic drug makers are effectively barred from introducing low-priced copycat versions, even after the patents on the original drugs have expired.
Without generic versions of their drugs, biotech drug makers enjoy an effective monopoly on each invention, setting their own prices without fear of competition.
Neil Minkoff , who oversees drug benefits at Harvard Pilgrim Heath Care , said biotech drugs aren't yet a huge strain on the healthcare system, but he worries what will happen as more reach the market without competition from generic versions to help control prices.
"The concern here is, as this continues to grow, what do we do if there's no outlet?" he said. For some rare diseases, "you're talking about decades of this, without the belief that it will ever be generic or there will ever be a decrease in prices. If you put a gun to my head and asked me what the biggest issue is for our industry, it's that there isn't this escape hatch."
The biotech industry argues that its drugs are too complex to be safely copied in the way traditional pill ingredients are duplicated to make generic pharmaceuticals. BIO's Greenwood visits Capitol Hill with a plastic model of a simple aspirin molecule, and a DVD with a far more complex biological molecule to attempt to convince legislators that biological drugs are so hard to make that they need special consideration.
Within the industry, leaders are aware of the need to keep up the image of the industry as special. James C. Mullen , chief executive of Biogen Idec and the current chairman of BIO, during a speech last fall at a Massachusetts biotech luncheon, urged the founders of younger, smaller companies "untainted by profits" to step up as the public face of biotechnology.
"You haven't done anything wrong -- your products don't cost too much, no one is denied your products," said Mullen, whose firm's $2 billion in annual sales makes it one of biotech's biggest winners.
"You are the underdogs in a David and Goliath story," he said to a throng of executives from smaller, money-losing firms hoping someday to get a drug approved. "America loves this story."
Stephen Heuser can be reached at sheuser@globe.com. 
