Opinion: Rushing New Drug Approval Puts Us in Danger

By Alexandra Johnston

Trusting doctors’ prescriptions may not be as safe as we think. Since 1992 the FDA has allowed “promising” drugs to skip trial stages to get on the market faster. Now, the FDA is considering further acceleration of the drug approval process, skipping even more of these important safety trial stages.

For the FDA to consider a drug “promising” it must match or outperform comparable drugs already on the market in both efficacy and safety after their phase one clinical trials. If the FDA declares a drug promising after the first clinical trials, it is exempt from phase three (the final phase) and sometimes phase two trials, allowing the drug to proceed directly to commercialization.

This leaves important safety testing at the bottom of the company’s to-do list as they transition from a research and development company to a marketing profit-driven team.

If the FDA approves a drug through the accelerated approval process, some of the effects of the new medicine are left unidentified because the testing was inadequate. The newly approved medicine could be working, or new users may misleadingly praise it for its short-term relief. Because of this incomplete approval process, we are left without enough data to show measurable clinical benefits or hazards, leaving users at risk.

GlaxoSmithKline's Avandia is an example of a drug that was approved too quickly. Avandia was originally prescribed to treat type 2 diabetes. But in 2007, Steven E. Nissen, M.D., a former member of the FDA & Department Chair of Cardiovascular Medicine at Cleveland Clinic, and his coworker and biostatistician Kathy Wolski, released a study revealing a different truth about Avandia.

They verified Avandia’s link to many cases of liver toxicity and heart attack, as well as a 43 percent increase in heart-related problems.

Although still on the market, the FDA has now made Glaxo re-label their drug, with a “black-box” warning, the most serious warning label the FDA can issue.

This label alerts users of potentially life-threatening side effects. Had this drug been thoroughly tested originally, these warning labels could have been released to begin with and prevented unnecessary harm to patients.

Lobbyists continue to press for legislation that would eliminate even more steps of the accelerated approval process. Recurring bills and initiatives continue to pressure the FDA to permit approvals based on any “compelling” data, sanctioning lengthy and expensive studies to occur after medicines have gone commercial.

Some initiatives proposed in 2012 that aimed to expedite drug approval included: The Advancing Breakthrough Therapies for Patients Act, Transforming the Regulatory Environment to Accelerate Access to Treatments Act, or simply TREAT; and The Faster Access to Specialized Therapies (FAST). Both bills died and were referred to committee. Congress undoubtedly will see more of this type of legislation in the future.

There are at least three companies in the Bay Area with medicines under current review by the FDA for possible accelerated approval.

• Theravance, a biotech company in South San Francisco, expects approval by May 12th for their drug Fluticasone furoate /Vilanterol for chronic obstructive pulmonary disease, or difficulty breathing.
• Raptor Pharmaceuticals, just north of San Francisco in Novato, is waiting for approval of their rare disease drug RP103 for potential treatment of nephropathiccystinosis. The FDA expects to reach a verdict on this kidney treatment by April 30.
• The third company is MAP Pharmaceuticals. Headquartered in Mountain View, this company should have results by April 15 for their drug Levadex for treatment of migraines in adults.

According to the FDA, from 1992 to 2008 the agency has approved 90 medicines through the accelerated approval process, which equates to approximately 10 percent of total drugs approved during this time period.

These approvals average half the time of the normal drug approval process.

Only two-thirds of drugs approved by the accelerated process have followed through with the final phases of post-approval tests. This leaves as many as 30 approved drugs on the market with few statistically-proven benefits and unknown effects of prolonged use.

As companies go through the drug approval process they meet with FDA representatives to discuss progress. If they can convince the FDA to put their drug on the fast track, they will reach commercialization quicker, and will finally profit from years of research, trials, and searching for funding.

The public does benefit from the accelerated approval process. For example, if a drug is potentially life saving and there is an immediate need, it could be useful to have the drug available sooner. This life-saving potential is exactly what places so much pressure on the FDA and is why the path to approval continues to be rushed.

Realistically, any drug-skipping safety trials should remain at the documentation level of an experimental drug rather than one that is FDA-certified for safety. If the FDA continues to bypass safety and efficacy, where do we draw the line for the future?

The FDA’s job is to ensure public safety. Without measurable results for hazards or benefits, it is unfair for the FDA to assure the public of the safety of these drugs with premature approval.

(Editor's Note: Alexandra Johnston is a sophomore at Santa Clara University studying English and Communications, apjohnston@scu.edu, and wrote this piece for Patch. Sarah Ebbott, also an English major at SCU, contributed to the editing process.)

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