The Real Problem with the FDA
Kurtz, Howie
The Real Problem with the FDAbv Howie Kurtz In early 1974 G.D. Searle and Company was preparing to release on the market a new artificial sweetener called aspartame. A white,...
...Some doctors also have been guilty of testing abuses...
...The FDA is also investigating the Industrial Bio-Test Laboratory , where inspectors have found that the number of tumors in some animals has been substantially under-reported...
...Robin eventually pleaded no contest to criminal charges, was fined, and was placed on probation...
...The investigators concluded that Searle had distorted and falsified some of its data on aspartame...
...Searle Company, we have no basis for such reliance now...
...Over a million pounds of Red Dye No...
...Companies still pay for the research on their own products...
...No slides were made of lesions found in some of the dead animals...
...The present system seems to work...
...It’s financially impossible to have the federal inspectors check up on everyone...
...The FDA, however, wants to let the industry keep doing the testing...
...That’s like relying on a neighborhood restaurant to conduct its own investigation into whether it has committed health violations...
...But while this is a step in the right direction, it won’t solve the problem...
...Third-party testing would cause grumbling about government meddling, of course, but it would not be especially expensive or dilatory...
...Thousands of people suffered such reactions before an FDA inspector in 1969 found information about the drug’s harmful effects buried in Upjohn’s files...
...The lab’s records also show animals dying repeatedly on different occasions from different causes...
...only half have been tested for toxicity...
...they pleaded no contest and got six months’ probation each...
...after all, people’s lives are at stake...
...Some people also died from taking the antibiotic Panalba, once one of the most frequently prescribed drugs in the country...
...Searle: “At the heart of FDA’s regulatory process is its ability to rely upon the integrity of the basic safety data submitted by sponsors of regulated products...
...We found brain damage at the lowest effective dose we fed the mice,” Olney said, “which is not a big amount if you’re talking about a sweetener to be gobbled up by children and infants.’’ A consumer group called LABEL cited studies that suggested aspartame could cause mental retardation in infants if consumed by pregnant women...
...One of the monkeys that received MER-29 had become ill and lost considerable weight...
...There were discrepancies between Searle’s raw data and the summaries it gave the FDA...
...A study by its manufacturer, Allied Chemical, shows that the dye causes malignant lymphomas, a form of cancerbut the FDA’s response so far has been to appoint a committee to spend two years studying the matter...
...So in December 1975 the FDA withdrew its approval of aspartame, before any had been sold...
...The firm was fined $80,000...
...Even to the extent that it is, it’s well worth it...
...Even when companies decide not to test their products themselves and farm them out to independent 60 researchers, there is subtle pressure...
...and Howie Kurtz is an investigative- reporter for columnist Jack Anderson.created a special investigative task force to examine the company’s testing procedures for aspartame and two other drugs...
...The drug was tested on monkeys by its manufacturer, William S. Merrell Company, and was approved by the FDA...
...ut if they turn out positive, then we go and shop around for another opinion...
...Our presumption is that the scientific and medical community is honest enough to resist any financial incentives...
...Three Merrell employees were indicted for submitting false information to the FDA...
...One FDA scientist says researchers who find fault with a company’s product may find they are not asked to participate in future studies...
...40, for example, is used every year in candy, cherries, soda, ice cream, frosting, and other foods...
...In July 1974 the FDA routinely approved it for general use...
...When test animals died in experiments, for example, Searle substituted the blood of other animals for the dead ones, the investigators said...
...Once the enterprising doctor was vacationing in Florida when he was supposed to be performing tests, the official says...
...More than 70 per cent of the additives on the list have never been tested to see if they cause cancer or birth defects...
...Subsequent FDA investigating turned up other discrepancies in the test results that made the drug appear less toxic than it actually was, and the FDA later began receiving reports that the drug was causing cataracts in humans...
...We don’t want to add another bureaucratic layer that would probably just delay things...
...Meanwhile, the stuff is allowed on the market...
...John Olney of Washington University School of Medicine in St...
...One of the more graphic cases involved MER-29, a drug used to lower cholesterol levels...
...But Robin never actually performed some of the tests...
...2, and the root beer flavoring saffrole were on the “Generally Regarded as Safe” list for years before being banned as cancer-causing agents...
...It wasn’t long, however, before independent scientists began to come up with disturbing evidence about aspartame...
...He concocted patients, he synthe-sized the doses-he made it all up,” one former FDA official recalls...
...Or, he says, “The drug company may call up the scientist and say, ‘We’re very interested in your research on suchandsuch, and we’d like to give you a $10,000 grant-as soon as this study is over.’ ” Discrepancies in the Results Although during the Nixon and Ford administrations the FDA hardly investigated products at all, the early sixties provided a wealth of examples of the hazards of corporate product testing...
...Its manufacturer, the Upjohn Company, never told the FDA that Panalba caused serious adverse reactions...
...Under his plan, the companies would still 62 pay fcr the research, but the FDA would award the contracts, so the scientists wouldn’t know where the money was coming from...
...Some of its employees were placed on probation...
...A white, odorless, crystalline powder that is 180 times as sweet as sugar, aspartame was meant for use in breakfast cereals, chewing gum, beverages, puddings, whipped toppings, coffee, and tea, among other things...
...Slowly, If At All Even when there is test evidence that a drug or food additive could be harmful, the FDA acts slowly, if at all, in protecting the public...
...In the early 1960s Dr...
...a normal, untreated, healthy monkey was quietly substituted for the sick one...
...Soon there was a deluge of such cases...
...We’re opposed to third-party testing because there’s no reason for it,” one FDA spokesman says...
...It’s unfortunate that when people think about the problems of the FDA these days, what comes to mind is not aspartame but a better known sweetener, saccharin...
...Of course, aspartame needed the approval of the Food and Drug Administration before it could go on the market, so Searle duly submitted test results showing it to be safe...
...As for the future of aspartame, that is in the hands of an independent group of scientists who lack any investigative experience and who will be paid by Searle for their efforts...
...As with Searle, so should it be with every company that makes drugs and food additives...
...More important, investigators discovered that the lab never performed some of the tests...
...Bennett A. Robin of Silver Spring, Maryland was testing new drugs for several companies...
...Our investigation clearly demonstrates that, in the G.D...
...One negative study by a pathologist was edited to make its findings appear more favorable...
...The agency compiled this list in 1958 on the basis of educated hunches and a little-answered questionnaire...
...A more accurate assessment came from the FDA’s own task force on G.D...
...Other potentially dangerous dyes have met with a similar response and are still on the market...
...Although Searle strongly denies it altered its data, the case has been turned over to a federal grand jury for prosecution...
...He submitted these imaginary results to the FDA, and many people died from taking the drugs...
...The FDA has found, for example, that Biometric Testing Inc., a laboratory that does contract work for a wide variety of chemical and pharmaceutical firms as well as government agencies, uses poorly trained and supervised technicians, inadequate record-keeping, unsanitary conditions, and unhealthy test animals at the lab...
...was charged with making false statements to the FDA and intentionally concealing information about its tranquilizer Dornwal...
...McNeill Laboratories, a subsidiary of Johnson and Johnson, concealed information from the FDA about a muscle relaxant called Flexin...
...Congress has reacted to findings like this by giving the FDA $16 million this year to hire more inspectors to look into the drug industry’s testing...
...In 1964 Wallace and Tiernan Inc...
...The company did not contest the charge and was fined...
...What about aspartame, and other incidents like it...
...Some people died from taking Dornwal, which the firm neglected to mention can cause a fatal blood disorder...
...Of the more than 2,500 food additives, artificial colors, and artificial flavors already on the market, fewer than half have been tested at all...
...And more drugs and additives are coming on the market every day...
...If you think Searle is going to pay all this money and not have any say in the finding,” says one FDA official, “you’re kidding yourself...
...The drug caused at least 50 cases of liver damage, eleven of them fatal...
...Senator Gaylord Nelson, Capitol Hill’s most persistent critic of corporate drug testing, has a more practicable solution to the problem: have all testing done by third parties with no ties to the companies involved...
...Louis said he had fed aspartame to mice and they developed brain lesions...
...We look at the tests, and if they turn out negative, fine,” says one FDA scientist...
...As the pressure and evidence mounted, the FDA agreed to take a second look at Searle’s data...
...But a former Merrell employee told the agency in 1962 that she had been ordered to falsify the original tests...
...Cyclamates, Red Dye No...
...One need not think these companies are evil or incompetent to see that letting them do their own testing on matters where huge profits hang in the balance is just providing a temptation to wrongdoing...
...What testing does go on began fairly recently...
...The enormous unpopularity of the saccharin ban has sparked various reform moves in exactly the wrong direction, and neatly obscured a gaping flaw in the way the agency goes about its business: it decides whether or not to let a product go on the market on the basis of tests financed (and often directly conducted) by the product’s own manufacturer...
...It’s practically an invitation to the companies to cheat...
...In addition, the agency has issued new regulations that clinical laboratories must follow in their testing procedures...
...More recent revelations show that some clinical laboratories are also unreliable...
...Saccharin, for example, used to be one of 439 additives on an FDA list of substances “Generally Regarded as Safe,” which means the FDA is not yet convinced that they are unsafe...
...Apparently that didn’t prove much of a deterrent...
Vol. 9 • July 1977 • No. 5
