The Minneapolis Star from Minneapolis, Minnesota • Page 6

The Minneapolis Star Thursday, June 28, 1979 Critics assail humaii testin. 6A g' of dlra new drugs be proven both safe and effective before marketing. The amendment provided for two post-test categories: Category 1 for drugs proven both safe and effective, and Category 2 for those found to be either unsafe or ineffective. Category 3, created by the (Sleep aids, from Page ia) possible. If they don't cooperate we end up in court, which takes forever.

What can you do? That's the regulatory system under which we work," she said. Both methapyrilene and pyrlla-mine were deemed safe in FDA tests during the 1940s. But because pyrilamine has not been subjected to the newer, more sophisticated testing that found methapyrilene unsafe, the FDA has placed it in a controversial classification: "Evidence lacking, to remain on market until manufacturers produce data." That classification amounts to a gaping hole in drug regulation, critics say. Because it would be to the manufacturers' disadvantage to find pyrilamine or any other drug harmful, there Is little incentive for them to test It. Although test data for pyrilamine Is absent, the scientist who tested methapyrilene for the National Cancer Institute suspects that pyrilamine, too, may cause cancer.

worried. Pyrilamine is extremely similar to methapyrilene, virtually identical. It differs in only one portion of the molecule, and the parts I think may be responsible for carcinogenic activity are identical," said the scientist, William Lijinsky, who Is director of the Chemical Carcinogenesis Program at the Frederick Cancer Research' Center In Frederick, Md. Lijinsky, who has worked for 30 years In cancer research, also conducted the research that showed that nitrites, chemicals commonly used In food preservatives, cause cancer. He expects eventually to test pyrilamine also.

"The companies should have to test drugs, not the government. As it Is, it could be six months before the FDA asks me to begin pyrilamine tests," Lijinsky said. Essential ingredient? Lijinsky discontinued the metha- fiyrilene tests after an unusually arge number of his test animals died of massive liver tumors. He reports that three or four animals a week are still dying, although he stopped testing several weeks ago. Drug company officials said they were shocked at the results, but agreed that they were accurate.

"What we are now doing is test ing this thing (pyrilamine) on human beings," Lijinsky said. "Why not wait to see if it's safe? When the law allows a drug to be sold when It's not proven safe, then the law's deficient." But drug companies claim pyrilamine Is an essential ingredient of non-prescription sleep aids. Most antihistlmines induce drowsiness. "We're using pyrilamine because it's all that's left," said John Wal-den, vice president of the Proprietary Association, a Washington, D.C., organization representing drug manufacturers. Walden said two other acceptable antihistamines exist, but one is for prescription use only and the other Is under exclusive license to Pfizer a New York-based pharmaceutical firm.

"The use of pyrilamine is an economic decision. Drug companies want to continue marketing legitimate sleep aids," Walden said. "Ll-jinsky's argument is with the FDA. We abide by the FDA as long as we think they're reasonable. If we think they re capricious we'll go to court." The FDA administers the Food and Drug Act, passed in 1906, and amended in 1962 to require that all lamine substitute but that the FDA is blocking its use in over-the-counter drugs.

a Scheckman said a review panel recommended diphenhydramine for non-prescription use several years ago. "But the FDA has not acted," he said. "It (the study) should be completed, especially in this area where we have a problem." "Diphenhydramine has not been tested adequately," Lijinsky said. "It's been assigned to us to test, but there Isn't enough money, I'd do it if I had the money. It may be another year before I can begin testing it, and the results are at least two years away." Scheckman is annoyed that Pfizer Co.

has exclusive rights to the second antihistamine, doxyla-mine. He said he doubts that Pfizer tested doxylamine for carcinogenic properties. But a spokesman at Pfizer's New York headquarters reported the drug was found safe in tests on animals. Pfizer conducted and financed testing of the drug, which will be sold under the brand name Unlsom. According to the FDA's Peterson, Pfizer was given exclusive marketing rights "as a sort of reward for financing the testing." "Doxylamine should be released for use by all drug companies," Scheckman said.

"It will eventually be put in Category 1 and we'll go after a new drug application. Doxylamine is more effective than pyrilamine." Other products to be reformulated with pyrilamine include Com-poz, Nervine, Sleep-eze, Sleepinall and Cope. The FDA could ban pyrilamine, said Dach, but bans on Category 3 drugs are rare. "We can't ban it," said the FDA's Nida. "The companies would take us to court, and the courts would demand proof." "This is the way the law Is set up," Lijinsky said.

"Most things are tested on human beings. I call It 'large Kale carcinogenic tests on human "We are in business and we cannot test everything for cancer," Scheckman said. The drug companies can't afford testing, he said, and the public would be harmed if Important drugs were removed from the market for testing. J.B. Williams Co.

will continue using pyrilamine In Sominex "because we don't think pyrilamine is carcinogenic. We won't remove it from the market Just because Lijinsky, one scientist, thinks it may be carcinogenic. It's Just his opinion. He has no proof." Scheckman said the company is doing "what every other company is Waiting for the FDA to finish testing possible substitute antihistamines. "If there is concern, then I'd think the FDA would accelerate Its study of pyrilamine and publish monographs on alternative drugs," he said.

"The government is there to protect the public. It's never been suggested we do routine carcinogenic studies. If the government suggested we did, then we'd do them'' Lijinsky -questions the need for sleep aids that contain untested ingredients: "If pyrilamine is the only alternative, then why do we need any? Because of advertising. The drug companies simply aren very responsible in these things." Asked if he considered Sominex a necessity, Scheckman said, "Well, of course not, but what is a necessity? We take all kinds of things that aren't necessities." But many people who use over-the-counter sleep aids have grown dependent on them. And many other people use the drugs occasionally- "There's easily several million sleep-aid users," said Ed Nida, an FDA press official.

"And millions are spent yearly on advertising." Incomplete testing Both Walden and Scheckman claim that diphenhydramine, the antihistamine currently restricted to prescription use, Is a viable pyri Labor's Virgil Moline has clout candidates seek sar Helpful new service: MICHIGAN GAS-OLINE telephone us toll free. the city. He always walks into a room angry and with a chip on his shoulder. Danny Gustafson (former business agent for the building trades and now vice president of the state AFL-CIO) was tough, but he had an idea of what needed to be done." To those that say this hurts the CLUC endorsements, Moline responds, "If labor's endorsement isn't worth anything in this city and they never say that to my face then how come they all come asking for It? They have to seek our endorsement; we don't go out and offer it. A lot of elections are won by relatively few votes." This friction has strained the relationship between labor and the DFL Party to the point that several years ago Moline talked of forming a labor party.

Moline said, "The chairman of the 5th District DFL, Lee Munnich, seems to want to taunt us by holding party functions in non-union establishments. I won't go to them. Fraser did the same thing. He had one function in the Butler Building. "This Is our business.

The hotel and restaurant workers are our largest local. We probably should've picketed it, but I didn't want to hurt Don." The recent victories of Irv Stern In St. Louis Park and Frank Rodri- Moline Torn to Page 7A 0 rDA tor untested drug ingredients, is at the center of what one FDA official called "this sensitive situation." Overwhelming task About 2,000 drug ingredients already on the market In 1962 were "grandfathered," meaning they could be used pending tests for safety and efficacy. The FDA placed these drugs in the controversial third category. Panels of scientists and medical doctors were funded to evaluate these drugs.

But after 17 yean, half of the grandfathered drugs remain in Category 3. The FDA recently estimated that the evaluation program will not be completed for 12 years. It is an overwhelming Job, according to Henry P. Roberts, director of the FDA's Minneapolis office. "The panels are still working, but it simply requires an inordinate amount of time.

There Is also the constant demand for evaluating new drugs on the market, which the panels also handle." FDA critics say Category 3, into which pyrilamine falls, is illegal. "The Food and Drug Act requires that a drug be proven both safe and effective. Category 3 drugs are not proven," said Leslie Dach, science associate for the Environmental Defense Fund in Washington, D.C. The fund is the non-profit environmental law firm that petitioned the FDA to recall methapyrilene. "The profit-making drug companies don't want to assume responsibility for testing their drugs," Dach said.

"They want it done at government expense. Testing costs can run high, so Category 3 was created to prevent economic disruption in the drug Industry. The companies claim they can't afford all the testing, but spend large amounts for advertising." Tough to trace If the choice is between testing or advertising drugs, Dach believes the public would prefer testing. "As It is, it's common practice for drug manufacturers to use untested ingredients in their products. It's an economic choice.

And if the drug causes cancer It's virtually impossible to sue them and prove it," Dach said. Cancer may not appear until 25 years after exposure to a carcinogen, making it nearly impossible to trace its cause. "I don't know if pyrilamine is carcinogenic or not. It hasn't been tested," said Dr. Edward Scheck-man, medical consultant to the J.B.

Williams manufacturer of So-minex. His company began reformulating Sominex about two months ago and is now marketing it with pyrilamine. Hennepin 379-2321 Canon AE-1 With 50mm 1.8 lens ONtr'269'5 Canon AT-1 With 50mm 1.8 lens 0NIY229 CANON 100mm 2J FD 100mm Macro 135mm 3.5 FD 135mm 1 FD 200mm 4.0 FD 200mm 2.8 FD 300mm 5Jb FD 289M 11 159" 173M 330" 275M '420" 80-200 Zoom STOCK ARE ON SALE mm Lr-iJLi (Moline from Page 1a) fective tools to accomplish labor's goals. politicians speculate that Moline privately is pushing Rice's candidacy among CLUC delegates. In a rare Interview, Moline dented any favoritism.

"Both Fraser or Rice would be good (as mayor). I'd hate to say which one I favor. Both are friends of labor, but in different ways," he said. "We are a local body. We are more concerned with local issues.

I hud contact with Rice almost every day during the legislative session. Sure, Fraser has supported labor In Congress, but his votes didn't hit me every day the way Is-shps do at the Capitol. '''Don's a friend, and Jim's a Mend. But Don has not helped us 00 the local scene." 'Moline's statement hints at the reason the CLUC has not jumped at the chance to endorse Fraser. It also suggests why some politicians say Moline's single-minded rule has hurt the CLUC politically.

The Janet Clark-Jim Adams contest for a legislative seat almost six years ago still sticks in Moline's craw. Seniority had given a Close friend of Moline, a key role in determining who got House committee chairmanships. However: Clark defeated Adams for the DFL endorsement, and Fraser supported Clark, who won the election. fVThe minute Jim Adams didn't get the DFL endorsement, Fraser went to work for his opponent. Now Jim is an electrician in City Hall," Moline said.

'A similar incident occurred in 1976 when Fraser backed DFL-en-d0rsed candidate Jeff Spartz for Htnnepin County commissioner ojier the CLUC-endorsed incumbers, Richard Hanson. What about Green? explained his actions by saying he believes in keeping political parties and the endorsement system strong. In light of Fraser's past actions, Moline raised the matter of Zollie Green, 9th Ward alderman who carries CLUC endorsement for the primary but lost the DFL endorsement to Tony Scallon. about Zollie Green? Will the same thing happen? We've got to Hook at who will help the overall labor ticket," Moline said. Therein lies the crux of the debate between some politicians and labor over the way the CLUC has handed out endorsements.

The politicians feel the CLUC demands 1 OP-percent loyalty from them and support for labor-endorsed candidates in other races and labor issues. On the other hand, labor feels some politicians want union contri- tAKOf 1HCAI 91 AGf ORDER NOW! NO WAITING Free Insulated Door 30 Years Experience 5 Year Warranty Garage Removal Specialists Licensed and Bonded Ow Ouilili vGARACE. Travel worry free. A quick call will keep you current on gasoline availability on all major travel arteries throughout Michigan Upper and Lower Peninsula The information is provided by the Automobile Club of Michigan and the Michigan Travel Bureau Lines are open 24 hours a day every day of the week OuKiStale, dial 800-248-5700 (toll tree) In Mkhitfnn. dial 800292-2520 (toll free) for wh'ation InJnrmation and gaaailne Call Now! 322 East Cameras and Mr.

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For instance, consider the case of Alderman Mark Kaplan, 8th Ward DFLer who upset CLUC-endorsed Incumbent Tom Ogdahl two years ago. Kaplan, formerly a teacher In West St. Paul schools, is not anti-labor. In fact, he represented his teachers' union in wage negotiations with the school board. But, because Kaplan supports easing rules so more minorities can get city jobs, and because he has criticized the use of tax increment financing and supported pension reforms, the CLUC probably will not support htm this year.

"By endorsing or not endorsing, the CLUC tends to create the friendships or lack thereof," Kaplan said. "As a result, certain people whose natural inclination is to take a pro-labor stand have not been as close to labor as they might otherwise." 3 have endorsement Another case centers on Aldermen Alice Ralnville, DFL-4th Ward, and Walter Dzledzic, DFL-lst Ward. In the past, they've carried CLUC endorsement. But this year CLUC appears to be withholding endorsement because they did not sign a letter criticizing a plan for pension reform proposed by the city council and mayor. However, the aldermen did vote against the plan.

In fact, the only aldermen who currently carry CLUC endorsement are the three who did sign the letter Green, Dennis Schul-stad, 12th Ward independent, and Patrick Daugherty, DFL-3rd Ward. These "grudges" are the reason some politicians dislike Moline's style. One politician said, "Vlrge doesn't take a very broad view of 10 Year Bank Financing Terms to Fit Your Budget Arranged in Your Home FREE 755-6600 Hennepin 379-2321 Opitz from Nikon NIKON FM Motor drive capability, uses A 1 lenses, LED readout, and more Nikon in it. 00 NIKON FEI0DY SHU COO 9 1 4V SCftOO 2i9V and FLASHES IN STOCK THE NEW A THE CANON AV-1 $050,00 With 50mm 1.8 bV CANON POWII WINDER with case $89" CANON SPEEDLITE issa with case '59" CANON F-1N BODY 429" CANON A-1 IN STOCK CANON MA MOTOR DRIVE SET IN STOCK NEW CANON A-35F $1150 CANON 111 $112M 20mm3.5 $364 105mm2.5.......26900 24mm 2.7 $269M 135mm 3.5.......M6400 28mm 2.8 $285M 135mm 2.7.......2290 28mm 3.5 176M 200mm4.0 $27900 35mm 2.0 300mm 5.6.......M1900 35mm 2.8 500mm 7.0.......$5200' 55mm macro ....218 43-86 Zoom 85mm 2.0 '234 80-200 Wv ALL CANON LENSES ARE ON SALE 24mm 2Jt FD 28mm 2JFD. 35mm 24 FD.

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