In this context, it is very important to understand that the only people who will be used as subjects in testing medical marijuana will be those for whom nothing else works. That is another difference between testing medical marijuana and the tests described here.)

See
HHS Announcement On New Medical Marijuana Research Rules
Shows It Is The Same Old Game.
and links

May 7, 1999

Clinical Trials

N E W Y O R K, May 6 — Each year, hundreds of thousands of Americans enroll in clinical trials. No one knows the exact number because there is no one is keeping track.

No one in government or industry is keeping track of how many people are killed or injured taking part in these experiments.

"There’s more protection offered animals in research than humans," says Dr. Eric Cassell of Cornell Medical College. "But the reason is, while that seems shocking, the reason is we expect humans to be able to protect themselves."

But there is evidence that’s often not the case and that some studies expose people to risks they never accepted.

The problem can be flagrant. In 1998, a survey of 394 academic and medical institutions found that 9 percent had suspended a research project because no patient consent was ever obtained. Then there’s the subtler problem of the consent document itself. Forms can be 11 pages long and are often crammed with unfamiliar terms.

"They describe it in the language of medicine or the language of science and you wouldn’t have the foggiest idea of what they were talking about," says Cassell.

Often the patient turns for advice to those running the experiment. But researchers want to enroll volunteers, not scare them away.

Individual Benefit Not Priority

"The process of describing what’s going on is slanted toward emphasizing the benefits and minimizing the risks," says Professor Alexander Capron of the University of Southern California.

What’s also often "minimized" is just what it means to go from patient to research subject, and how, instead of having access to treatments that have been proven effective, a person is limited to that one treatment being tested.

"The purpose of doing research is to produce knowledge, not to produce a benefit for the individual," says Capron.

Review boards at medical centers across the country are supposed to oversee these studies and make sure patients know just what they’re getting into. But there are now so many studies that some boards are becoming overwhelmed, often leaving patients to fend for themselves.

Copyright ©1999 ABC News Internet Ventures.

May 10, 1999

FDA Moves to Reduce Accidental Drug Deaths

Health: Agency to unveil strategy today to prevent fatalities blamed on misuse of prescriptions.

By MARLENE CIMONS, Times Staff Writer

WASHINGTON—More than 100,000 Americans are inadvertently killed every year by prescription drugs—one of the leading causes of death in the country.

But the majority of such deaths are preventable, the result of mistakes or confusion about dosage, dangerous drug interactions from mixing medications or known allergic reactions. Some patients, especially the elderly, die because their liver or kidneys are so weakened by other illnesses that they cannot effectively process new drugs.

Alarmed by such drug-induced fatalities, the Food and Drug Administration is talking with leading drug companies, the American Medical Assn., hospitals and consumer groups seeking ways—together and individually—to further protect patients.

In a 150-page document expected to be released today, the FDA plans to unveil some of its initiatives. These include an upgraded computer network that will allow drug companies to report unexpected adverse reactions quickly and a new approach to language about the known side effects of prescription drugs that will give patients and doctors better and clearer warnings.

The actions were prompted in part by a study published in the Journal of the American Medical Assn. last year that concluded that adverse drug reactions are among the top six causes of death in the United States.

But other factors also propelled the issue to the top of the FDA’s agenda. Under pressure from patients and politicians for faster access to promising medications, the FDA has in recent years moved drugs more rapidly through the regulatory pipeline. Such speed raises the risk once a drug is in widespread use.

Over the last two years, the FDA has recalled five drugs and moved to reevaluate several others, including the diabetes drug Rezulin, whose problems were detailed in a Times series last year, and the Parkinson’s medication Tasmar, both of which have caused instances of liver failure. Whether Rezulin will remain on the market is still under debate.

"More can be done" overall to enhance public safety, said FDA Commissioner Jane E. Henney, who shortly after being confirmed by the Senate in October created a task force to study the drug approval process. She predicted in an interview that the effect of the changes "will be tremendous."

Some of the changes are underway, and others are in the talking stages.

Among them:

• An $8-million computer upgrade that will enlist the nation’s 13 leading drug companies to immediately report any sudden and unexpected reactions to recently licensed drugs. This replaces a computer index that was linked to a paper-based file that was cumbersome and slowed the agency’s ability to respond quickly, said Dr. Janet Woodcock, director of the FDA’s center for drug evaluation and research.

The new system means the "FDA can learn about trends faster and act on them faster," Woodcock said.

• An international agreement among U.S. drug regulators and those in Europe and Japan to use the same terminology to describe drug reactions or causes of death so that global trends can be more clearly and rapidly identified. "Since companies are now marketing around the world, adopting these [standardized terms is] a major undertaking," Woodcock said. For all nations to use the same language "gives us the best chance possible to find something and spot a trend."

• Revised drug information for physicians that will highlight precautions about drugs in an easier-to-find format so doctors don’t have to search through pages of detailed information to find what they need to know about possible drug reactions. The FDA plans to propose this within a year.

The drug industry has expressed some concerns about the changes, fearing that industry liability could increase as a result of doctors missing something important.

"I don’t think it’s possible to condense all the key information on prescription drugs into such a simplified, standardized format," said Marjorie Powell, assistant general counsel for the Pharmaceutical Research and Manufacturers of America, an industry trade group. "It raises lots of things that a creative plaintiff’s lawyer could argue in court."

But Nancy Ostrove, an FDA official involved in drafting the labeling overhaul, countered: "Their concern is that by highlighting certain information it will discourage prescribers from reading the rest. We don’t believe that, because we think they aren’t reading it now."

Nor are doctors always talking about it with their patients. Many feel hampered by the managed care climate, which has shortened the time they spend with their patients. Also, many physicians, traditionally trained to stick to a few drugs for any particular condition, now are forced by certain health plans to use specific drugs, some of which they may not be familiar with.

• New information for consumers. Up to 10 new products annually—those deemed by the FDA to have the riskiest side effects—will carry new, easy-to-understand warning information for the patients themselves. Currently, only certain categories of products, such as hormone replacement therapy or drugs with extremely dangerous side effects such as thalidomide, contain such information. "We believe that the more educated consumers are, the safer they are going to be," Woodcock said.

However, many experts acknowledge that it is tough to get consumers to pay attention—either to labels or to their own doctors. The FDA is looking for more ways to encourage consumers to become more involved in their own health. The agency already sponsors community education outreach programs for women through its women’s health office and would like to expand these programs "if we could find the resources to do it," Woodcock said.

• Better coordination, including the increased use of computers, to avoid medication errors arising from confusion over similar brand names. Problems occurred recently, for example, over prescribing practices for the new pain reliever Celebrex, close in name to the antidepressant Celexa, as well as the epilepsy drug Cerebyx.

"We have the ability to forbid a name that’s too similar—we do turn down names—but we can’t always do as close a review as we like," Woodcock said. "We need computers to do name comparisons in advance."

• Designated hospitals to monitor and report drug reactions. The program would be modeled on an existing pilot project that watches for adverse reactions to heart valves, implants and other medical devices.

The FDA stresses that tackling adverse drug reactions is not something it can do alone.

The agency’s primary responsibility is ensuring that a drug is safe and effective before it reaches the market, and it has the authority to remove a drug from circulation if it proves dangerous. But it cannot regulate how doctors practice medicine, how pharmacists fill prescriptions or what consumers do once the drug reaches their medicine cabinet.

Dr. Nancy Dickey, president of the AMA, believes that the problems need to be addressed by everyone in the system, with novel ways to protect consumers—much like surgeons and hospitals seeking to avoid mistakes by putting ink on a patient’s body at the site where the operation is to occur.

"We are looking for that equivalent for prescription drugs—a change in the entire system—that could help prevent mistakes," she said.