December, 1991

GAY PEOPLE'S CHRONICLE

FDA is moving to speed up drug approval process

by Dave Gilden

With the historic approval of a second AIDS drug behind it, the Food and Drug Administration is moving to formalize an expedited process for approving vitally needed therapies.

The FDA licensed ddl, the new AIDS drug, on the basis of safety data and preliminary indications of effectiveness. Had the agency insisted on the traditional proof of improvement in physical symptoms and then conducted its usual plodding review of that evidence, another three years could have elapsed before ddl was commercially available.

In an internal draft document leaked to the Bay Area Reporter, FDA Commissioner David Kessler proposes applying the ddI precedent to any drug to treat "serious or life-threatening illnesses for which there is no satisfactory alternative therapy.

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Besides AIDS and HIV infection, such maladies as cancer, heart disease, depression, asthma, rheumatoid arthritis and diabetes would fall within the scope of the revised procedures. Covered also would be situations in which a certain subset of the patients with a particular disease do not respond well to the standard treatment.

Kessler wants to make two innovations to accelerate the drug-review process. One is the use of "surrogate endpoints" to confirm drug-trial results before there is an obvious improvement in patients' survival or

physical well-being. Surrogate endpoints are laboratory measurements thought to precede changes in clinical symptoms.

For AIDS, the most famous marker of this nature is the helper T-cell count, which characteristically declines as the disease progresses.

But the human body is not a mathematically determined machine, and the linkage between laboratory measurements and physical signs is not tight. Some people with a very low helper T-cell count manage to stay symptom-free, for example. And people on AZT generally do better than others with the same helper T-cell count who are not taking the drug.

To resolve this fuzziness, the FDA is considering requiring post-marketing studies for drugs licensed on the basis of surrogate endpoints. The pharmaceutical company would be required to conduct further studies to ascertain its medication's actual benefits in human beings.

The proposal also calls for accelerated withdrawal of drugs on occasions in which the post-marketing studies turn out poorly.

Withdrawal could be ordered after a quickly

constituted hearing in which the appropriate FDA advisory panel of experts would review

the company's and the agency's arguments

Manufacturers would agree to this withdrawal procedure when applying for accelerated approval. If the company objects, its product will be reviewed through

Northeast Ohio lesbian and gay archive opens at Historical Society

The Northeast Ohio Lesbian-Gay Archives will be inaugurated on December 14 with a donation from the Lesbian Gay Community Service Center. With help from Robert Ridinger a complete set of the Gay People's Chronicle, and a complete set of High Gear magazine have been assembled on microfilm, which will be donated to the Western Reserve Historical Society. There are also some other periodicals of lesbian and gay organizations, records from the old GEAR Center, posters and advertisements

for gay-oriented events and some board minutes from the Center.

The archives would like to expand its collection; we are particularly interested in old letters and diaries, and any printed material from before Stonewall. If you have any questions, please contact the Center at 522-1999.

John Grabowsky at the Western Reserve Historical Society is their representative on this project. He can be reached at the Society at 721-5722. ▼

NOCI picnic earns over $12,000

Northern Ohio Coalition, Inc has released the financial figures from this year's "We Are Family" Picnic, held Sept. 8 at Wildwood Lake Park in Columbia Station.

Income:

Admissions (2,466 persons) $38,808.00

Expenses (cont'd)

Raffle Sales

3,226.00

Motor Home/Truck Rentals

776.20

Concession Fees

220.00

Toilet Rentals

512.00

Emperor/Empress

2,054.04

Security

1,050.00

NOCI Pin Giveaways

646.60

Total Income

$44,308.04

Electrician/Lakeland Labor

631.50

Awards Expense

122.25

Expenses:

Decorating Expense

284.00

Wildwood Lake Park

$17,688.50

Miscellaneous Expense

858.47

House of LaRose (Beer)

4,066.00

Tickets/Advertising

2,120.25

Total Expenses

$31,938.67

Sound System Rental

1.250.00

Raffle Expense

1,932.90

Net Income

$12,369.37

the traditional slow and exacting process.

Kessler's proposal probably will be published in the Federal Register in December and be open for public comment for 60 days thereafter. Rep. Tom Campbell, R-San Mateo, has written a bill now before the House of Representatives that would force the FDA to adopt many of the measures Kessler has outlined plus ensure that insurance companies pay for drugs expeditiously approved. While now endorsed by 35 representatives, many of them Democrats, that bill's future is uncertain.

A major debate is developing over how expedited approval can be policed against abuse. Unless the FDA keeps track of them, pharmaceutical companies may do the research necessary for expedited approval and then delay or misreport the required post-marketing tests.

Many substances look good at first, only to prove disappointing later. Just last March the Journal of the American Medical Association reported a very promising study of Imuthiol in people with AIDS. Yet one of

Page 5

the report's authors later told the B.A.R. the Imuthiol only looked good because cases of AIDS dementia were disregarded. In July the drug's French sponsor announced it was withdrawing its support of Imuthiol because a large European study on people with HIV could find no benefit form its application.

There are already scandals under the FDA's standard process in which companies are found to conceal negative data. The most recent of these involves psychotic reactions to the popular sleeping pill Halcion, licensed by the FDA in 1982.

Billions of dollars ride on drug approvals. Both a company's profits and the price of its stock are affected. Streamlining the FDA process may be only half the struggle in this charged atmosphere. The other half is to get that financially beleaguered agency to efficiently follow through on the procedures that it enacts.

Reprinted with permission from the Bay Area Reporter, San Francisco.

Third Community Service Awards dinner January 19 at Snickers

The Gay People's Chronicle will present its annual Community Service awards Sunday, January 19, at Snickers Restaurant. Dinner will begin at 6:00 p.m.; the awards will be presented at 7:30.

The Community Service Awards are presented by the Editorial Board of the Chronicle and are meant to highlight people and events of Northeast Ohio's lesbian and gay community. Awards given are: Woman of the Year, Man of the Year, Women's Group, Men's Group, Mixed Group, Event of the Year and Friend to the Community. The Friend of the Community Award is given to someone outside of the lesbian and gay community who has demonstrated interest in and caring to the community.

Winners will be announced in the January issue of the Chronicle, where their

Report Anti-Gay Violence

contributions also will be documented. Invitations will be sent to all Chronicle subscribers in mid-December.

Although this is the third year the awards have been given, this is the first where dinner has been served beforehand. The community is invited to help honor those men and women who have best served the community. The event will serve as a fund-raiser for the Chronicle.

Dinner with the awards ceremony will cost $25. The ceremony itself will start at for dinner must be received by January 6 at 7:301 0p.m. and admission is $10. Reservations the Chronicle offices. Everyone is welcome to attend. If you are not a subscriber and would like an official invitation, please call 621-5280 and ask to be added to the invitation mailing list.

This includes verbal abuse, threats, vandalism and police abuse, as well as physical assault. If hate crimes aren't reported, authorities don't know they're happening.

■Call the police at 911, if they aren't already involved. Let them know this is a hate

crime.

Call the Center at 781-6736 or 522-1999. Their Maryann Finegan Project will help you with police, prosecutors, and courts; and give counseling and support.

Call the U.S. Justice Dept.'s Hate Crimes Hotline, at 800-347-4283. Federal law requires them to keep statistics on anti-gay crimes-numbers which can be used to prove the need for legislation.

Benefactor will match donations toNational Coming Out Day

National Coming Out Day (NCOD) has received a "Challenge Grant" from openly gay philanthropist and major political activist Jim Hormel.

Hormel has been a consistent and generous supporter of NCOD since its inception in 1988 and most recently was the NCOD spokesperson at the October 11 rally in Sacramento opposing Governor Pete Wilson's veto of AB 101, the lesbian and gay employment protection bill.

Hormel has offered to match all contributions of $250 or more (up to a total of$5000) that come in between now and December 31.

"We encourage all lesbians and gay men who are supporters of the National Coming Out Campaign to become substantial contributors during this challenge grant. They can get the most bang for their buck,' said Lynn Shepodd, Executive Director of National Coming Out Day.

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National Coming Out Day is a non-profit organization dedicated to a lesbian and gay community living openly, powerfully and equally in society. To make a contribution, or for more information, please call or write: National Coming Out Day, PO Box 8349, Santa Fe, NM 87504-8349, 505-982-2558 or 800-445-NOOD.V

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