It’s Up to Senate To Undo House Damage to Research

Posted August 8, 2003 at 2:28pm

Unless the Senate acts decisively, 2003 could be a catastrophic year for medical research — and for millions of people who suffer from dread diseases or will do so in the future.

The House, with massive short-sightedness, has voted not only to cut the federal budget for disease research, but also to curtail the ability of pharmaceutical companies to develop new drugs.

[IMGCAP(1)] The Senate can undo the damage by increasing the appropriation for the National Institutes of Health (and getting the House to go along with the boost) while also defeating efforts to permit re-importation of drugs from foreign countries where prices are controlled and safety is not guaranteed.

In the wee hours of July 25, the House voted 243-186 to permit re-importation of drugs from Canada and two dozen other countries without giving the Food and Drug Administration authority to monitor their safety.

Members were motivated by outrage at high drug prices and the differential between U.S. and foreign prices, neglecting to observe that life-saving drugs won’t exist if pharmaceutical companies can’t make profits to invest in new research.

Various Members complained that monthly doses of the breast cancer drug Tamoxifen cost $360 in the United States and $60 in Germany, and that a prescription for the blood pressure medicine Toprol-XL costs $108 here and $40 in Canada.

But the House majority ignored the fact that by reducing drug company income by up to $700 million a year, it is depriving the companies of the capital they invest in new medicines to treat cancer, heart disease and other ailments.

Canada, Germany and other countries can keep drug prices down by imposing price controls. It’s no accident that more than 80 percent of the world’s new drug development occurs in the United States.

That will stop if the United States, in effect, adopts price controls by foreign proxy. Drug companies won’t be able to invest the $500 million it costs, on average, to bring one new drug to market.

The way to reduce drug prices — at least for seniors — is not to mandate prices, but to pass a Medicare prescription drug benefit. In future years, Congress should also help the uninsured obtain health coverage, including a drug benefit.

In its haste to reduce drug prices, the House also dismissed dire warnings from the Bush administration that the bill it was passing is dangerous.

FDA Commissioner Mark McClellan, who’s been working to reduce drug costs by various means short of price controls, said the House bill would allow importation of “expired, subpotent, contaminated or counterfeit” products.

Advocates of the bill claimed that Canada has drug-clearance procedures as safe as those in this country, but McClellan noted that Canada does not guarantee the safety of drugs shipped out of its own territory.

Moreover, he said, drugs imported from Canada, Japan, Europe, Australia or South Africa “could potentially be manufactured and trans-shipped from anywhere in the world.”

The FDA has evidence, he wrote, of “prescription drug sales from Internet sites that purport to be in Canada, but upon investigation have been found to be located elsewhere and provided drugs that are adulterated, sub-potent or counterfeit.”

Supporters of the re-importation bill, including Republicans, accused the FDA of having been captured by the drug industry, but Donna Shalala, secretary of Health and Human Services under President Bill Clinton, also refused to certify that imported drugs could be guaranteed as safe.

The House majority that passed the re-importation bill included 155 Democrats and 87 Republicans. It will be on their heads if the measure becomes law and people die from adulterated drugs — or from diseases not cured because appropriate drugs were not developed.

Fortunately, a bipartisan group of 53 Senators — including Democrats such as Edward Kennedy (Mass.), Barbara Mikulski (Md.) and Patty Murray (Wash.) — has signed a letter calling for maintenance of current FDA safety controls.

Meantime, it’s up to the Senate to undo NIH budget cuts pushed by both the Bush administration and the House. NIH funds the basic medical research that eventually leads to development of drugs by pharmaceutical companies.

Prior to this year, President Bush and Congress doubled the NIH budget over a five-year period, providing annual increases of 15 percent and significantly advancing medical discovery.

However, Bush decided to drop the initiative — and forgo a potentially luminous legacy of disease cures — by recommending a budget increase this year of only 2.5 percent, below the rate of medical inflation of 3.1 percent.

The House went along with the Bush number, while the Senate Appropriations Committee passed a 3.7 percent increase.

Biomedical scientists and medical school deans argue that a drop-off in the pace of funding from 15 percent to 2 percent to 3 percent would cause havoc in the research community, forcing labs to close and projects to be dropped.

When the appropriation for the Labor, Health and Human Services, and Education departments hits the Senate floor in September, Sens. Dianne Feinstein (D-Calif.), Tom Harkin (D-Iowa) and Arlen Specter

(R-Pa.) intend to offer an amendment increasing NIH funding by 8.5 percent.

Specter’s support is crucial because he’s chairman of the Appropriations subcommittee overseeing NIH, but the measure still needs 60 votes to pass.

Millions of people depend — whether they know it or not — on both federally funded and drug company research to save their lives. Members of Congress, if they help these people, surely find a way to let their constituents know about it.