Author goes after drug firms

Pharmaceutical companies will need a new miracle pain reliever after the whipping they receive from Dr. Marcia Angell in her book “The Truth About Drug Companies: How They Deceive Us and What We Can Do About It.”

Angell’s relentless, take-no-prisoners indictment of the industry could not come at a worse time for “big pharma.” The companies are trying to fend off profit-busting political movements that would allow the importation of cheaper Canadian drugs and authorize state and federal governments to negotiate wholesale prices for Medicare and Medicaid drugs.

Like a zealous prosecutor, the former editor in chief of the prestigious New England Journal of Medicine allows no mitigating arguments in her attack.

The core of the book slams the drug companies’ central argument in current policy debates – that high drug prices are necessary to support research and development of innovative new treatments.

Angell argues that research and development costs are wildly inflated by drug companies, and only a handful of truly new drugs reach the market each year. She says innovative drugs most likely are based not on the work of drug company scientists but on taxpayer-funded research at public universities, and drug companies mostly produce “me too” drugs, or derivations of existing drugs, that do little to improve the lives of Americans.

Furthermore, she writes, drug companies owe their exorbitant profits to favorable tax breaks and regulatory decisions, and they control almost every aspect of the drug approval process. She also says the industry also faces little scrutiny from a compliant U.S. Food and Drug Administration, Congress and White House – all are beneficiaries of industry largess.

Drug companies do have huge expenses, Angell says. They spend tens of billions of dollars on what are essentially kickbacks to doctors for prescribing their drugs, as well as supporting hundreds of lobbyists who protect their interests in Washington, D.C., and lawyers who work to extend patent rights that keep drug prices high. Consumers, she said, pick up the costs.

Ouch.

With drugs the fastest-rising part of a skyrocketing national health-care bill, Angell does raise important issues that should be addressed by presidential candidates. Why is it so much cheaper to import American-made drugs from Canada than to buy them here? Why shouldn’t state and federal governments negotiate wholesale prices for drugs for programs like Medicare and Medicaid?

There is no gray in Angell’s analysis, but there should be in the public debate.

For instance, Angell seems to suggest dramatically trimming drug companies’ profits would limit their ability to buy legislators and regulators, an argument that would lead to the collapse of the U.S. economy if applied to all industries with lobbyists in Washington.

Angell’s reform list is politically unpalatable, but it serves as a starting point for serious discussion. She strongly urges that drugs be awarded patents only if they are proved to be better than existing therapies — not just better than placebos, which is the current benchmark. There might be other ways to spur innovation, rather than simply to cut off marginal improvements in drug development. Angell argues that the average cost of developing most drugs on the market is closer to $100 million than industry estimates of $800 million.

She does concede that truly innovative drugs are very expensive to produce — perhaps $400 million a year or more by her own estimate. So-called “me too” drugs do help industries keep the bottom line in the black. So perhaps the government can preserve the most favorable patent and pricing protection for drug companies that truly fill unmet medical needs. Patients desperately need truly innovative drugs, such as the cancer-fighting breakthrough Gleevac. But does the world really need a seventh or eighth cholesterol-lowering statin?

Some steps would not have huge economic consequences. There is compelling evidence that the work of academic researchers who accept drug company dollars tend to favor drug company products. But industry cash has leveraged taxpayer-funded research and, in turn, increased the odds of truly innovative biomedical research having a favorable impact for consumers. Scientists — and journal editors like Angell — should continue making voluntary steps in rooting out bias in research they review and publish.

After reading this book, there still will be arguments among readers on the best path to take. But there will be few Bush, Kerry or Nader supporters who advocate the status quo in how we regulate the pharmaceutical industry. Angell raises important issues that should be addressed by presidential candidates.