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About Medford mail tribune. (Medford, Or.) 1909-1989 | View Entire Issue (Aug. 30, 1962)
THUHSDAY, AUGUST 30, 1962 MEDFORD MAIL TRIBUNE. MEDFORD, OREGON MEDFORD MAIL TRIBUNE. MEDFORD. OREGON THURSDAY. AUGUST 30. 1362 ispatch Tells Why Administration Wants Jef Drug Legislation German FHitnr'. Not: Stirred by 1 h thalidomide tragedy. Congress it talcing a close look at America'! drug con trol lawi. Preiident Ken nedy ayi new legiilation ii needed to protect the public from "unsafe and worthies! drug products." Pharma ceutical manufacturers warn that "unnecessarily extreme" controls may de lay introduction of life saving medications. The fol lowing dispatch tells why the administration thinks specific proposals now in Congress are necessary and why, in soma instances, the drug industry is opposed to them. By LOUIS CASSELS Washington - - Amer ica has the strictest drug con trol laws of any nation on earth. But the agency which en forces these laws, the U.S. Food & Drug Administration (FDA), has been warning for years that they are strict only by comparison with the rel atively lax requirements of other countries. It has said repeatedly there are danger ous loopholes which ought to be plugged. The FDA's pleas for new legislation have met with con siderable resistance from the $3.5 billion pharmaceutical industry, which contends that too much government regula tion will do more harm than good by stifling progress in drug development. The drug manufacturers seemed to be winning the argument, so fBr as Congress was concerned, until the re cent thalidomide scare. This country's close call with the baby-deforming drug put Congress in the mood to pass a bill. Legislative proposals which President Kennedy made on behalf of the FDA last March have been re trieved from committee pigeonholes in the House and Senate. Early action seems likely. . The major administration proposals around which con gressional debate will center are: LICENSING NEW DRUGS Under present law, a new drug may- to placed on (he market 60 days after the manufacturer has submitted a licensing application unless the FDA intervenes to block it. If the FDA is dubious about a new drug, but lacks evi dence to supress it outright, it may stall for months or years by demanding further information or raising succes sive objections to the details of the application. That's how FDA mcriicul officer Frances O. Kclscy spared Americans from a thalidomide disaster. But as the law Is now worded, FDA scientists feel they are under pressure to let a drug go on the market unless they can demonstrate it's unsafe. Under the proposed legis lation, the "affirmative ap proval" of the FDA would be required before any new drug could be marketed. If the FDA failed to clear an ap plication within a reasonable time, the manufacturer could demand a hearing. But the burden of proving the drug safe would clearly rest upon the manufacturer. Drug manufacturers con tend the FDA already has adequate powers to require complete proof of a drug's safety before letting It reach the market. They say animal tests, clinical trials and other evidence demanded hy FDA In a new drug application often fill a six-foot sheld of ' volumes. The new procedures, they say. would permit bureaucratic inertia to delay the introduction of valuable new medicines. EFFECTIVENESS OF NEW DRUGS Present law does not re quire a manufacturer to prove a new drug is effective as well as safe. Even if the FDA has a good reason to doubt the efficacy of a product, it has no choice but to let it. go on the market. Once it Is on sale, the FDA can seize It as a "mis branded" drug, but It must be prepared to offer proof In court that the drug won't do what the manufacturer has claimed for it. John L. Harvey, deputy commissioner of the FDA, re fers to this procedure as a "cat-and-mouse game which allows a manufacturer to fool the public with a worthless product until the government catches up with him." ' The new legislation would put the shoe on the other foot. The manufacturer would be required to prove his product is efjective, as well as safe, before it is lirensed for com mercial sale The Pharmaceutical Manu facturers association cI'MAt. which represents leading eth ical dnm houses, agreed "in principle" with this proposal. Bui it is anxious to have the law so worded that "substan tial evidence" of a drug's ef fectiveness will be enough to let it be placed in tne nanas 01 ohvsicians for trial. The ad ministration's bill calls for "preponderant evidence and (ho Hrn0 manufacturers fear that this language could block drugs whose ctficacy is ques tioned by some authorities, though others may consider them 01 tremendous nie-sav-ing value. REPORTS ON EXPERIENCE WITH NEW DHUUS In 10R1 Ihp Fn A learned belatedly that a muscle-relax ing drug, which had been on the market since 1956, had been implicated in 54 cases of DISTRESS CALL New York - Before thr let lers SOS were generally adopted as a distress signal, the letters CQD were often jmd. hpnatitis. including 15 deaths. After recalling the drug from the market, it discovered that the manufacturer had been accumulating reports of these adverse reactions for five years without saying anything about them. The new legislation would require drug companies to make regular reports to the FDA on clinical experience with the new drugs. WITHDRAWAL OF DRUGS Serious side effects of a new drug may not become ap parent until it has been in use for some time. That hap pened with thalidomide. It also happened in this country with MER29, which was widely used for lowering blood cholesterol levels. By last November, FDA had learned of four cases in which patients taking MER 29 had developed eye cata racts. Government scientists wanted to suspend the drug but were told they had no legal power to do so under present law unless they could prove that MER29 was un safe when used in the dosage recommended on the label. Since the recommended dos sage had been exceeded in three of the four cataract cases, MER29 stayed on the market. Five months later, in mid April of this year, the FDA had acumulated evidence of enough injuries at the recom mended dosage to require the withdrawal of MER29. - The new legislation would permit immediate suspension of any drug when the FDA believes that it presents an "imminent hazard" to public health. Drug manufacturers hope some safeguards will be pro vided to insure that FDA's withdrawal powers are not used "capriciously." It would be a shame to have a good drug snatched of. the market because some government official panicked over a single complaint," said the head of one big pharma ceutical company. MANUFACTURING CONTROLS Last fall, complaints began to pour into FDA about a dietary supplement. Male pa tients using it were develop ing enlarged breasts. Female patients had abnormal uterine bleeding. Investigation showed careless manufactur ing processes had permitted the product to become con taminated with synthetic sex hormones produced in the same plant. Present law does not give the FDA the power to inspect drug manufacturing pro cesses, or to set minimum re quirements for manufacturing controls that will insure se curity. Most good drug houses are scrupulously careful on their own initiative. But there have been enough incidents like the sex hormones to show some of the nation's 1,300 drug manufacturers are not above cutting corners and taking chances with public health. The proposed legislation would empower the govern ment to set quality control standards for drug manufac ture and enforce them through plant inspection. The provision is viewed with considerable concern by an industry in which trade secrets are jealously guarded. Although the PMA has not taken a stand against inspec tion as such, it wants the FDA's investigating powers limited to matters directly af fecting drug safety. OTHER PROVISIONS Other provisions of the legislation would: require ad vance government safety cer tification for all types of anti biotics (only five of the 35 types in wide use are now subject to certification). Require that drugs be iderv tified on their labels by their standard pharmacological names as well as by the manu facturer's brand name. Tighten federal controls over barbituates and stimu lant drugs such as ampheta mines which now are being sold illegally in many areas. Require that medical adver tisements for new drugs ad vise doctors about their bad as well as their good effects. Doctor Dis cusses Phocomelia A 7 and Its Treatment (Editor's note Thousands of babies were born with arm and leg deformities in Europe during the last two or three years. In most cases, the mothers had taken the drug thalidomide during pregnancy. Ger many, hard hit by deformi ties, is taking the lead in treating the handicapped children, A German doctor discusses the problem in ihe following dispatch.) By ZANDER HOLLANDER Frankfurt, Germany tUPli ."When the nurse told me about our baby, it was like a blow from God. "But now I know he is a person, a human spirit. We love him even more than our other normal children. We be lieve he can have a decent life if we do the right things for him now." Dr. Ekkchard Stoerig, sen ior physician of the Frankfurt University Orthopedic clinic, nodded warm agreement as Hans Schmidt let us call him that described lis feel ings about the son born to his wife two years ago with badly deformed arms and legs. Schmidt's son is one of an estimated 3,000 to 5,000 chil dren born in Germany with such phocomelia or seal-like deformities during the past three years. In almost all cases the mothers had taken "Contergan" pills. Contcrgan is the German trade name for the tranquilizer drug thali domide. More Advanced Because the drug tragedy hit Germany so hard. Dr. Stoerig ruefully says German , doctors and therapists prob ably are further advanced in I caring for the tiny phoco ! meiia victims than those of other countries. "We have made great strides in developing therapy techniques and prosthetic ar tificial limbs. We had to," Stoerig says. "But most im portant we have learned you must begin right away to treat the babies. We used to think there was little point to prosthetic limbs until the pa tient was ready to start work. Now we know to wait is disastrous." The Frankfurt clinic re ceived one or two phocomelia cases a year before the wave of birth deformities. Sudden ly in I960 there were 10 de formed babies; in 1961 there were 22, and in the first five months of 1962 there were five. Phocomelia is no respecter of classes. Parents of deform ed babies included an interior decorator, an automobile me chanic, a tool factory worker, a doctor on the Frankfurt clin ic staff and thousands of oth ers from all walks of life. "Your first reaction is pan-1 ic you ask yourself over and over, why us?" said the doctor. It was 18 months ago that his wife, who took Con tcrgan to counter sleepless ness, gave birth to a son with clubbed and crippled arms. "Then comes reconciliation as you icarn to know and love the child, and you realize you and he must make the best of it. "That is when you must listen to your heart." The doctor and his wife ac cept the fact that their son will always be physically handicapped. "But he could become a good doctor." the father said. "We hope for him just as for any other 18-month-old, and we try to treat him the same. Of course there are differ ences if he reached for some thing - he is learning to grab with his pinkie. We do have hope that we can help him to have a good life." Now Loves Him A pretty, brown - haired young mother whose deform ed baby is only six months old, said, "At first I hoped he would die he's my first, t But now I love him." Dr. Stoerig began therapy on this woman's son a few days ago. "First we must prevent any further damage," he explains. "Deformed limbs can lead to deformed spines without speedy corrective treatment. "Then twisted arms or legs must be straightened. A twist ed stump is a shaky base for an artificial leg. "Those little fingers in the shoulders are valuable - they CO FFEE EDWARDS Rich and robust. 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Shop Safeway for all your outdoor and indoor food needs at money-saving, low prices! SAFEWAY WQLL BE OPEN MONDAY, SEPT. 3 9 a.m. to 9 p.m. A aw i i i.. iii. , fc .I t wr am x '"tfA rot jrit n Cut-Up FRY JtK&fi-T1 ' . '. lute n f 'A'Ti A 1 Manor House USDA Grade "A". Gov't, inspected. Guaranteed to be the freshest tasting fryer you ever ate. Let's have a patio picnic. ) , vsi ' ..J1.W i jt mm J.w W'r III USDA CHOICE arm cut. Round bop. beef roast Ground fresh. Extra lean and flavorful Pot Roast Ground Chuck I ..nAL HaiIa Sf-y- Mognt, plckl.-pimento, LUIIUII media .Pi. Canned Hams Diced loaf, or olive. 6 ox. Dubuque or Armour's Star. Wast, fr.e, easy to fix ib 69c 59c 4S1 79c FRANKS Popular brands; fresh for your holiday. 12 oz. pkg. mj Chuck Steaks USDA CHOICE grade. Ideal for outdoor cooking. Ib. 59 c MONEY SAVERS Mushrooms ihsl. t.r Mayonnaise Bit Food ecu 29c . 59c Reg. Silt Cart. Cigarettes ch?,'loliG4 $1i79 f rcnch'l Worcestershire Sauce . 23c Shortening wHXm 3 lbl. 59c Bumble Bee Tuna Z'Zll, 35c Instant Milk r,20q7.Pk,. 87c SCOTT PAPER SPECIALS Toilet Tissue I Waldorf I Napkins Th. t,t Roll. Pk9. of 4 53c Softts, trontit, nictft, Pkg, ( 4 39c Remember... We Give Valuable Gold Bond Stamps Gold Bond Stamps are an EXTRA dividend on everything you purchase. Gold Bond means FREE Gifts by the nation's foremost manufacturers for you! s,.,,,, 229c , must not be allowed to atro I phy. We strengthen them by LsDecial pxprrisps Whpn th. time comes those fingers will operate the controls of a pneu matically . powered artificial arm." Dr. Stoerig has graphic proof that rehabilitation is possible. One picture sshows a smiling two-year-old girl with out arms. Others show the same little girl two years old er, building with blocks, wheeling a doll carriage and playing a toy xylophone all with artifical arms. Therapy Costly The therapy is costly. Dr. Stoerig estimates a child's prosthetic limb costs from 2, 000 to 3,000 marks (S500 to $750). The child probably will need perhaps three or four sets of artificial limbs before he is ready for final adult- size limbs capable of refined adult movements. The West German federal health ministry is now devis ing ways to help families of such babies shoulder the eco nomic burden. "The child must have these things," says Stoerig. "When the time comes for normal children to play patty-cake, these infants must have limbs capable of patty-cake. When they enter school and must learn to write they must al ready have mastered pros thetic arms capable of hold ing pencils, and writing. "These children are physi cally one down from the mo ment of birth," Stoerig puts it. "They must be made equal or even one up on nor mal people mentally." Equally Capable Stoerig and his colleagues agree phocomelia babies are as Intelligent as normal babies and equally capable of learn ing. "It's more than a medical job," Stoerig tells phocome lia parents. "Our job is to build the child's confidence, to surround him with love and, understanding, to make sure he never loses contact with the real world in which he will have to make his way." "There is a moment I dread," the interior decorator said. "One day my child will be playing in a sand pile with other children and someone will say, look at that cripple. "But we are too fast to throw a life away nowadays. We will not throw away this one. It will be hard,, but he deserves a chance. He Rives me and my wife much joy." Butterfly's Love Life Discussed at Science Meeting Corvallis - IUPII - The short, huppy love life of the butter fly provided a light interlude here today for thousands of scientist gathered to discuss the wide aspects of biology. The report on butterfly ro mancing was delivered by Dr. Lincoln P. Brower and Dr. Florence Cranston of Amherst college at the American In stitute of Biological Sciences convention. The male of the beautiful Queen butterfly uses per fumed "hair pencils" to en tice his lady, they said. Pursuas Female The male pursues the fe male, overtakes ner in the air, and induces her to alight by brushin" her with the scented sticks, they told the Amer ican Society of Zoologists. Then the courtship pro ceeds. If the lady is willing she folds her wings, while the male rubs her head with his antennae. Then, In an age-old tradi tion, they say, "he carries her to an inconspicious spot," where the happy pair rest mo tionless for hours. The court ship often ends without mat ing, the scientists added. The report was one of many delivered today, covering topics ranging from bats and crabs to the unity of biolog ical science. Dr. Curt Stern, president of the American Society of Zoologists, said in spite of its separate approaches, the unity jf biological science is becom ing more apparent. Unifying Factors He said separate animal and plant sciences are being re-evaluated in terms of their place In the overall structure of learning. And, he said, there is a need for emphasis on unifying factors. Dr. Asher Treat of City Col lege, New York, reported on a clever mite that lives in the car of a moth. The moth needs its hearing to avoid being eaten by bats, he said. The mites avoid their own destruction, he said, by never infesting but one car of any moth. Other reports covered habits of hermit crabs that live in empty snail shells, her editary mongolism, and "how much nucleus Is enough for one cell." lei COPYRIGHT, SAFEWAV STORES I.SCORPORATta
