The Pain Relief Network

There are many promising new cancer treatments in the pipeline, but under current Food and Drug Administration (FDA) regulations, almost no one gains access to them, no matter how dire the need or how compelling the evidence that the drugs work.

Most people receiving a terminal cancer diagnosis die before the most promising treatments in the pipeline reach them. Why? Because those tragic events occur on the wrong side of the magical moment when someone at the FDA puts an approval letter on a fax machine declaring the drug they needed – and never got – is "safe and effective."

Congress now has an opportunity to address this problem thanks to Sen. Sam Brownback (R., Kan.) and Rep. Diane Watson (D., Calif.), who recently introduced the Access, Compassion, Care, and Ethics for Seriously Ill Patients Act. The Access Act, said Mr. Brownback at a press conference introducing the bill, provides that "terminally ill patients whose medical needs are unmet by currently available options would be granted access to promising, investigational treatments."

As Ms. Watson observed at the same press conference, "The activism of the AIDS community in the 1990s expedited the marketing to the general public of promising antiretroviral drugs. Today it is my understanding that many AIDS drugs do not have to go through the controversial and questionable Phase III testing with placebo controls. Sadly, the expedited approval of promising new drugs for cancer patients and patients with other life-threatening diseases does not receive the same attention or expedited approval."

We know from personal experience – having received similar diagnoses for our spouses – what Mr. Kennedy and his family face, and it is our hope that he be given access to any promising treatment that can give him the best chance of extending his life. We support that access even if he gets it only because of who he is, a Kennedy and a U.S. senator. Our national shame is that humane access to effective drugs is not available to all with terminal illnesses.

Among the promising new therapies that should be available to Mr. Kennedy is a vaccine being developed at Duke University. The vaccine trains the body's immune system to kill malignant tumor cells, but to leave healthy cells alone. It is safe and effective, increasing average survival for patients with malignant gliomas like Mr. Kennedy's from 14 months to 33 months, based on the results of clinical trials presented in Chicago at a conference on cancer recently. Although the number of patients treated so far is small, the magnitude of the estimated survival difference and the strength of the underlying science makes it very unlikely that the positive effect is due to chance.

But the vaccine faces additional years of randomized trials in which a few hundred patients will get, or not get, the vaccine before the FDA considers approving it. Given what we know about the vaccine, the ethical problems with such trials are obvious, but the FDA will rigidly demand them.

In the meantime, the thousands who won't get into the trials will die waiting. What will we learn? That the survival advantage is a month or two less, or more, than the 19 months already estimated. That's it.

Mr. Kennedy's situation, identical from a regulatory standpoint to the plight of hundreds of thousands of other Americans, shouts to the heavens the humane necessity of urgent reform in the drug approval process to make it work better for people who have serious and terminal diseases.

The Access Act creates a new approval mechanism called Compassionate Investigational Access (CIA) for patients who can't wait. Patients receiving a CIA drug must suffer from a serious or life-threatening disease, be out of approved options and unable to gain access to a clinical trial, provide informed consent, and allow the collection of clinical data from their experience with the drug so we will all know more about the safety and efficacy of new therapies before they are approved for wider use.

The Access Act also improves the FDA's accelerated approval mechanism that has helped to preserve the lives of HIV/AIDS sufferers, but has never been adequately applied to other serious diseases like cancer.

Before his diagnosis, Mr. Kennedy was working on legislation to reinvigorate the war on cancer. The Access Act belongs in that package. Some of his friends in the Senate, including Democrat Bob Casey and Republican Arlen Specter of Pennsylvania, co-sponsors of the Access Act, will support him.

The unavoidable reality for people with a terminal disease is that good cancer drugs are held up behind a one-size-fits-all regulatory wall. The Access Act offers Congress, and Mr. Kennedy, a way to help break the regulatory logjam for all of us.

Mr. Walker is chief adviser and co-founder, and Mr. Trowbridge is adjunct scholar, of the Abigail Alliance for Better Access to Developmental Drugs.

Smoking marijuana isn't a harbinger of ruin
By Jacob Sullum

According to the federal government's survey data, at least half of American adults born after Word War II have tried marijuana. Because people may not be completely candid about illegal behavior even in a confidential survey, the true percentage is probably higher. And many of those who have never smoked pot no doubt know people who did, yet somehow emerged unscathed from the experience.

That is the typical pattern for illegal drug users. Again, judging from the government's own data, the vast majority of them, including those who try drugs said to be instantly addictive, never become heavy users. Yet politicians feel constrained to pretend otherwise, lest they be accused of being soft on drugs or irresponsibly encouraging American youth to experiment with illicit intoxicants.

Bill Clinton absurdly insisted that he had smoked pot without inhaling. His successor has implicitly conceded that he used illegal drugs when he was younger, but he refuses to discuss the details. "If I were you," George W. Bush told a Newsweek interviewer in 1998, "I wouldn't tell your kids that you smoked pot unless you want 'em to smoke pot. I think it's important for leaders, and parents, not to send mixed signals. I don't want some kid saying, 'Well, Gov. Bush tried it.' "

Although Barack Obama has been unusually candid about his youthful drug use, he has stuck to the conventional narrative of sin and redemption, suggesting that he was well on his way to death from a heroin overdose because he smoked pot in high school and college. Even so, Obama's comments have attracted criticism from drug warriors. Last fall, former Republican presidential candidate Mitt Romney said, "It's just not a good idea for people running for president of the United States who potentially could be the role model for a lot of people to talk about their personal failings while they were kids because it opens the doorway to other kids thinking, 'Well, I can do that too and become president of the United States.' "

The thing is, that happens to be demonstrably true. Prohibitionists have invented a whole sub-genre of anti-drug propaganda to deal with this inconvenient reality. They argue that marijuana today is so much stronger than it used to be — 30 times as strong, according to White House drug czar John P. Walters — that it's not even the same drug as the stuff that Clinton, Bush, Obama, Al Gore, Newt Gingrich and other major political figures managed to smoke without wrecking their lives.

There's little question that average THC content, marijuana's main psychoactive substance, has increased substantially since the 1970s, although not by anywhere near as much as Walters claims. But because the respiratory effects of smoking are the most serious health hazard cannabis poses, increased potency makes the drug less dangerous, allowing people to get the same effect with less exposure to combustion products. The potency argument therefore should be viewed as little more than an attempt to obscure something that most Americans know from their own direct or indirect experiences. Until politicians admit that smoking marijuana is not a harbinger of ruin but a generally harmless rite of passage, they will not be able to have an honest discussion about drug policy.

Jacob Sullum, a senior editor at Reason magazine and a nationally syndicated columnist, is the author of "Saying Yes: In Defense of Drug Use" (Tarcher/Penguin).
Would you want a president who's under the influence?
By Charles "Cully" Stimson

Jacob,

Imagine this:

It's 3 a.m., and a phone rings in the vice president's quarters. A Secret Service agent answers the phone, listens, and then rushes into the VP's bedroom with the phone in hand and wakes him up.

Agent (placing his hand over the mouthpiece of the phone): Mr. Vice President, the president of Xyzistan has threatened to launch a nuclear strike in 15 minutes. You must respond.

Vice president: Where is the heck is the president? Why isn't he taking the lead on this issue?

Agent: Sir, he's coming down from his heroin high. We tried to wake him up, sir, but he's out of it.

Vice president: Give me the darn phone.

Look, the issue is not whether some politicians fib about prior drug usage because they want to get elected — they do — but whether we want our leaders to reflect the best America has to offer. People look to politicians for leadership and to the president as a role model.

We're all fallible. Since the beginning of mankind, there have been and always will be temptations. Those include, but are not limited to, drugs and alcohol. Society's best and brightest — and whatever you think of their politics, presidential candidates tend to be extremely bright, highly capable individuals — can experiment with drugs or abuse alcohol early in their lives and get away with it, or nearly so.

But there are still consequences. Ultimately, each candidate had to recover from his experimentation of drugs or abuse of alcohol to become a viable contender for president. The reason is quite simple: Americans don't want to elect a known alcoholic or a drug addict as president, but they are willing to consider a candidate who overcame an addiction or made a bad choice as a youth and learned from those experiences.

We all know people who have abused drugs or alcohol. I used to work closely with an attorney; let's call him "Bob." Bob and I were friends; our families socialized. Our offices were right next to each others'. Bob graduated from prestigious universities. We tried cases against each other, but he never lived up to his potential as a trial attorney. One week I beat him at trial, and his performance was poor. The next week, he passed out during a different trial. It turns out he had been drinking a fifth of scotch a day for 12 years.

He got professional help, fights the urge to drink to this day, and is now a world-class advocate, father and husband. Just think, though, of all the clients he failed prior to getting help.

Here's the point: He chose to abuse alcohol and lived. If he had chosen, say, heroin, he would probably be dead.

Charles "Cully" Stimson was a local, state, and federal prosecutor, a military prosecutor and defense attorney, and deputy assistant secretary of defense. Currently, he is a senior legal fellow at the Heritage Foundation (heritage.org).

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