September #105 : How a Drug Becomes a Pill - by Ivan Oransky MD

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Kissing Babies

The Demons Behind the Down Low

Hello Our Name Is ATAC

Putting Out

The DL 411: Resources

Bedtime for Bonzo

Using My Religion

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Pos & Neg

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How a Drug Becomes a Pill


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Quick Study: Diarrhea

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Trouble for Tipranavir

HIV Spoken Here

Mouth Wide Shut

Married... with Virus


Lady in Waiting

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The HIV Life Cycle


Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV

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September 2004

How a Drug Becomes a Pill

by Ivan Oransky MD

Ivan Oransky, MD, peers into the pipeline to see what’s taking so long

And you thought the cable guy was slow. Tufts Center for the Study of Drug Development researchers say it takes about 10 to 15 years and $800 million for a drug to go from bright idea to pharmacy shelves. Industry critics such as Public Citizen call that figure inflated, saying that drug companies include massive marketing costs and that the real cost is closer to $100 million. Still, just one in 1,000 compounds graduates from the lab to a human clinical trial. It would be nice to know how a drug performs along the way, but drug companies aren’t required to publish study results (so they often “forget” to announce poor outcomes). Medical journals and the American Medical Association are now demanding that pharma tell all in a registry of trials and results. Here’s how a little pill goes to market.


Preclinical Testing
Old style: Researchers whip up a zillion compounds and stay up all night throwing them at HIV in test tubes, petri dishes and lab animals to see what sticks. New style: They use high-tech computerized models to “design” drugs to hit the virus. This stage includes in vitro studies (compounds are studied in human or animal cells and tissues) and in vivo studies (testing in living animals).
Takes: 3 to 4 years
Ticker: About 5 in 5,000 survive


Investigational New Drug Application (IND)
The Food and Drug Administration (FDA) has 30 days to nix an IND (rejection is rare if the paperwork is complete). An IND allows researchers to start clinical trials. Takes:Investigational New Drug Application (IND) The Food and Drug Administration (FDA) has 30 days to nix an IND (rejection is rare if the paperwork is complete). An IND allows researchers to start clinical trials.
Takes: Up to 1 month
Ticker: Just about all of the 5 left standing after Step 1 Up to 1 month


Phase I Trial
The first of three clinical-trial stages (only humans need apply) tests safety, not effectiveness. A med’s sponsor (drug company, academic group or federal agency) might pay healthy college kids to sit in a room and take a drug, then watches for rashes, pains or other toxic effects that would torpedo the drug. Healthy subjects are used (except when late-stage patients desperately need a med, say, for cancer or AIDS)—it’s easier to see that any symptoms they develop are from the drug, not a disease.
Takes: About 1 year
Ticker: 3 or 4 of the original 5,000


Phase II Trial
This phase determines safe dosage (enough to work but not enough to turn your hair green) and involves small numbers of people with the condition targeted by the drug. Testers begin looking at whether it works, too.
Takes: About 2 years
Ticker: 2 or 3 of the 5,000 starters


Phase III Trial
To test the drug’s effectiveness, hundreds or thousands of patients with the targeted condition take it. Most of these studies are controlled: Some people get the drug while others get a placebo (sugar pill) or a treatment already known to work.
Takes: About 3 years
Ticker: 1 of the original 5,000


Approval (or Not…)
Once the sponsor thinks it has proved a drug safe and effective, it submits a New Drug Application (NDA). This can run thousands of pages and includes animal and human test results. It details the compounds that make up the drug, how it’s manufactured and metabolized and samples of how it will be labeled. For HIV meds, the FDA accepts surrogate markers—measures of health improvement such as CD4 count and viral load—to indicate a drug’s success, rather than making pharma prove increased lifespan. That would take, well, a lifetime.
Takes: As little as 6 months—but averages about 21/2 years
Ticker: The 1 left standing after III


Marketing and Phase IV
Once a drug is approved, the ads and scrips roll out, but technically, the trials aren’t over. In Phase IV post-surveillance marketing, the sponsor should monitor patients for side effects detectable only in very large populations and in the long run: If there’s a rare side effect that afflicts one in 10,000 people, you won’t see it until 10,000 people are taking the drug. All HIVers who take a new med are part of this phase, so squeak up to Doc about sfx.

This Little Guinea Pig

Many people are eager to join trials for free medical care or compensation—and because they think they’ll get the latest, greatest treatment. But remember: There’s no guarantee that the trial drug will work safely or at all—and you might get stuck with a placebo. Ask your doctor for options or check out, a clearinghouse of U.S. government trials. Read the trial protocol and consent form carefully. Ask lots of questions at every step—don’t be afraid of being a pill yourself. And if you aren’t accepted, don’t feel unworthy. Subjects must fit rigorous criteria so trials can clear statisticians and the FDA. If you don’t make the cut, ask your doc about an expanded-access protocol, which would get you the drug before it hits the shelves.

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