PUBLIC CITIZEN HEALTH RESEARCH GROUP SIDNEY M. WOLFE, M. D., EDITOR APRIL 2001 + VOL. 17, NO . 4 Latin America: the Answer to Drug Companies' Problems? t never seems to end. Once again, While the researchers in the HIV foreign investigators registered with U.S. researchers are proposing a studies were generally government the FDA grew over five-fold in the I study in developing countries in scientists or academics who were ap­ decade of the 1990s. which poor people would receive pla­ parently committed to helping resi­ The latest scandal involves a biotech cebos instead of proven, lifesaving dents of the developing world, the new startup company in Doylestown, PA therapies. And this time, the U.S. gov­ wave of unethical research involves called Discovery Laboratories, which, ernment, in the form of the Food and the for-profit pharmaceutical industry in collaboration with Johnson & Drug Administration (FDA), is playing whose motives are far less clear. Seiz­ Johnson, manufactures an experimen­ a leading role. ing upon some of the same justifica­ tal drug called Surfaxin for the treat­ In April 1997, Public Citizen blew tions put forth by the HIV researchers ment of the often-fatal Respiratory the whistle on a set of 15 research ("they wouldn't have been treated any­ Distress Syndrome (RDS) in premature studies involving HIV -positive preg­ way"), drug companies are now invad­ infants. The drug belongs to a class nant women in which some of the ing the Third World with intent to called surfactants, which are naturally women were not given AZT, a drug conduct research that would be clearly occurring compounds that help the that had been shown to reduce dra­ unethical in the U.S. The number of continued on page 2 matically the transmission of HIV from mother to infant (Health Letter Vol. 14, No. 5). Instead of AZT, thousands of c: () N T E N T S women were given inactive drugs called placebos. Our criticism of those studies Election 2000 Commentators on ethical grounds unleashed an inter­ Read what Dr. Sidney Wolfe feels about the Ia~ five years at the FDA . ........................... ... ... ............... ... ............. ...... .. ................. ........... .. 2 national storm that has yet to abate; in fact, the storm has just struck a new Product Recalls front. February 12-March 12, 2001 The HIV trials resulted in an attempt Aspirin, knee support straps and candles are on our list this month ..... 3 by the research industry to greatly weaken the World Medical Association's One Drug Company-Scherlng-Plough-Faces Massive Recalls The only thing that was wrong with these asthma inhalers was the active (WMA) Declaration of Helsinki (Health ingredient got left out. ......................... .. .................................................... 7 Letter, Vol. 15, No.5). However, at its annual meeting in Edinburgh, Scotland High Drug Prices For Research or Profit? in October 2000, the WMA settled Most Health Letter readers already know the answer to this question . .. 8 upon the following language: "The benefits, risks, burdens and effective­ Is This Doc Deadly? His Practice Hasn't Been Perfect See what one doctor had to do before he was stopped from ness of a new method should be tested practicing. .................................................................................................. 9 against those of the best current pro­ phylactic, diagnostic, and therapeutic Outrage of the Month methods." The WMA also explicitly CASHCOW-Here a Moo, There a Moo rejected the notion that researchers can This outrage just "dropped in" to our email system courtesy of the New provide inferior care in poorer coun­ England]ournal ofMedicine . ...................... ..................................... ... 12 tries. \'ISIT IIL\LTII H.ESE.\HCII GH.OlTP'S WEB SITE AT WWW.CITIZEN.OH.G/IIRG/ Election 2000 Commentators The following article was written the standards for approval. provisions concerning presaiption drugs by Health Letter editor, Dr. Sidney Third, the August 1997 relaxing ofFDA were largely crafted by the pharmaceuti­ Wolfe and appeared in the publica­ requirements for 1V ads of presaiption cal industry, has made the FDA legally tion Medical Marketing and Media, a drugs has created a windfall for the most more friendly in a variety of ways to the journal directed at the pharmaceuti­ industry. cal industry. What has been good news for the pharmaceutical industry, however, is not he election of a Republican The FDA's good news for patients. The FDA's perfor­ President, after eight years of a mance during the past four or five years T Democrat leading the country, performance is worse than at any time in the past 30 might seem to be good news for the years, worse than under Presidents Nixon, pharmaceutical industry. However, the during the past Ford, Carter, Reagan or Bush the first. last several years of the Clinton regime Since it is hard to imagine how the FDA's have brought little but praise from the four or five years drug safety record can get worse, I am industry, which currently gives the [Food optimistic enough to hope that it will and Drug Administration] FDA the high­ is worse than at actually improve, prompted in part by the est marks I have witnessed in the 29+ extraordinary spate of drug safety with­ years I have monitored the pharmaceuti­ any time in the drawals in the past several years. The cal industry and the FDA. There are Congress will be no more constructive in several reasons for this, including the past 30 years its FDA oversight than it has been but relative silence and lack of aiticism of the there may be some effort to modify the industry in the media, especially 1V, by patient-endangering Dietary Supplement the current Commissioner, Dr. Jane Health and Education Act which has Henneyandherpredecessor,ActingCom­ heavily advertised products whose sales aippled the FDA's ability to regulate missioner Dr. Michael Friedman. have rocketed up with this massive, fre­ herbs and food supplements. Negotiated In addition, the 92 new drugs ap­ quently misleading 1V exposure. prices or price controls on presaiption proved in 1996 and 1997 are the largest Fourth, the passage and signing by drugs, at least for Medicare beneficiaries, number ever approved in a two-year President Clinton into law of the 1997 will be forced onto the table as part of the period, clearly the result of a lowering of FoodandDrugModemizationAct, whose consideration of a Medicare drug benefit. LATIN AMERICA, from page 1 pared to a known effective drug (with­ countries use surfactants, so the plan is lungs to inflate. When given to prema­ out a placebo group) as evidence of to conduct the experiment in those ture infants, mortality is reduced by 34 efficacy, FDA officials have been trying hospitals that don't-the race to the percent. There are four approved sur­ to persuade them to require placebo ethical bottom. factants on the U.S. market, selling at controls more often. The FDA is currently considering $1,100---$2,400 per course of treat­ But, as the FDA readily admits, whether to endorse this trial design, an ment. "Conduct of a placebo-controlled sur­ endorsement the company craves if it Discovery Laboratories is eager to factant trial for premature infants with is to gain access to the lucrative U.S. market its drug in the U.S. because 40 RDS is considered unethical in the market. The issue was raised at an percent of world-wide pharmaceutical USA." Indeed, the company is plan­ internal FDA meeting in late January sales occur in North America. But the ning a study in Europe in which its with the all-too-revealing title: "Use of company seeks to include a placebo drug is compared to an already ap­ placebo-controls in life threatening arm in the study. One reason for this is proved surfactant, without a placebo diseases: is the developing world the that it is easier for the company to group. answer?" demonstrate that its product is better This is where the developing world Public Citizen is concerned that this than nothing than to show that it is on comes in. The company has planned a is just the beginning of a new trend in a par with known effective drugs. placebo-controlled trial in Mexico, which the poverty of developing coun­ The company must also be well Bolivia, Peru and Ecuador, ensuring tries is used by drug companies and aware that the FDA has a long-standing that at least a dozen infants in the potentially the FDA to justify the provi­ love affair with inappropriate placebo­ placebo arm will die unnecessarily. sion of substandard medical care to controlled trials. Because European And these wouldn't be just any Latin their research subjects. The line in the regulators are more likely to accept American infants; the company and the sand must be drawn now. studies in which the new drug is com- FDA admit that some hospitals in these 2 • April 2001 Product Recalls February 12-Marcb 12,2001 I) R 11 c; s & I) 1 E T A R Y s 1 T P P L E ~~ E N T s his chart includes recalls from the Food and Drug Administration (FDA) Enforcement Report for drugs and dietary Tsupplements and Consumer Product Safety Commission (CPSC) recalls of consumer products. lbe recalls noted here reflect actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death. Class II recalls may cause temporary or medically reversible adverse health consequences.