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`CDC Meeting: 03/26/1997 Minutes and Agenda
`Regarding Thalidomide
`
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`CFAD VI 1014-0001
`
`

`
`(''~ DEPARTMENT OF HEAL TH & HUMAN SERVICES
`~ .... ,.~
`
`OCT 17 Dl3
`
`Public Health Service
`
`Centers for Disease Control
`and Prevention (CDC)
`Atlanta GA 30333
`
`October 3, 2003
`
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`
`Enclosures
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`
`CFAD VI 1014-0002
`
`

`
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`COC0.1227
`Rev. 5.'2001
`
`CFAD VI 1014-0003
`
`

`
`1 •
`
`PREVENTING BIRTH DEFECTS
`DUE TO THALIDOMIDE EXPOSURE
`
`Sheraton Colony Square Hotel
`Atlanta, Georgia
`
`March 26, 1997
`
`Birth Defects and Genetic Diseases Branch
`Centers for Disease Control and Prevention
`
`Denise Webster
`writer/editor
`
`CFAD VI 1014-0004
`
`

`
`PREVENTING BIRTH DEFECTS DUE TO THALIDOMIDE EXPOSURE
`
`Sheraton Colony Square Hotel
`Atlanta, Georgia
`March 26, 1997
`
`Dr. Dixie Snider, Associate Director for Science, CDC, welcomed the participants.
`
`Dr. Snider gave a synopsis of the history of Thalidomide and the role it played in changing the
`way drugs are approved for use in the United States. He stated that Thalidomide is used currently
`for the treatment of certain autoimmune disorders such as systemic. lupus, rheumatoid arthritis,
`HIV, and for leprosy. There is concern over the use of Thalidomide in Brazil, where it is readily
`available as an over the counter drug, since there appears to be little evidence that its use is
`discouraged in pregnant women.
`
`Dr. Snider stressed that if thalidomide is approved for use in the U.S., there must be strategies in
`place to reduce the risk of exposure of pregnant women to the drug. The goal is to avoid and/or
`reduce birth defects from all teratogenic drugs.
`
`After this meeting, CDC will publish its written guidelines in the Morbidity and Mortality
`Weekly Report (l\llMWR) sometime this coming fall. Today's participants will have the
`opportunity to review those guidelines, and comment on them, prior to publication.
`
`Assessment of Roche's Accutane Pregnancy Prevention Program~ Dr. Allen Mitchell,
`Professor of Epidemiology and Pediatrics, Boston University
`
`In the Fall of 1988, Roche Laboratories developed and implemented a Pregnancy Prevention
`Program for physicians, and women who were taking the drug Accutane. This education program
`included an information package for physicians, a comprehensive patient consent form, and a
`blister pack with an explicit warning against taking the drug while pregnant. Patients were
`strongly encouraged to participate in a voluntary survey, to judge compliance with the program.
`
`Enrollment opportunities are provided through physicians, the medication package, and a toll(cid:173)
`free telephone number, and women are paid $10 upon enrollment. Follow-up interviews are
`conducted by phone and mail. Study results were published in the New England Journal of
`Medicine in Fall of 1995.
`
`Survey results showed that the understanding of the need to avoid pregnancy while on Accutane,
`and the understanding of birth defects caused by Accutane, were high. The observation that 78~10
`of women waited for the results of pregnancy tests before taking Accutane prompted a change in
`the package warnings, and subsequently 85% reported waiting for test results prior to starting the
`drug. The self-selected participants tended to be well educated, and it is unclear whether they are
`
`CFAD VI 1014-0005
`
`

`
`representative of the total population of women taking Accutane.
`
`Q&A
`
`Dr. Godfrey Oakley, CDC: How many women take Accutane?
`
`Dr. Mitchell: We don1t know. The single biggest frustration with this study is the inability to get
`a meaningful and accurate denominator. Roche is very helpful, denominators are hard to identify .
`. The best guess is that 50% - 60% of treated women are enrolled in the study.
`
`Dr. Elizabeth Raymond, Family Health International: The low pregnancy rate in this study is
`impressive. Were the women under-reporting pregnancies?
`
`Dr. Mitchell: We struggled with this issue. There could be under-reporting. However, the low
`pregnancy rates are compatible with the whole point of the program which was to screen and
`eliminate high risk women from taking the drug.
`
`Dr. Paul McDonough, Medical College of Georgia: I was on the FDA committee that
`approved Accutane because of the clear effectiveness of the program. I'm disappointed, though,
`because I had high expectations, due to Roche's PPP. Although the results are low, they are not
`low enough. I was disappointed that the survey was only voluntary. Roche did a superb job with
`the educational materials. Although the statistics look good, one third (1/3) started the drug
`before getting pregnancy test results, and 1/3 started the drug prior to their next menstrual cycle.
`
`Dr. Mitchell: We lmew enrollment would be voluntary. We don1t see high pregnancy rates
`among noncompliant women (not to excuse MDs), but neither do we see a zero rate for those
`who are compliant. Two-thirds became pregnant due to contraceptive failure.
`
`Dr. James Mills, NIH: We did a study of growth hormone, and were able to track people. I
`would suggest that a registry is a good mechanism for tracking, and for ridding the study of the
`self-selection bias.
`
`Dr. Mitchell: I agree; a universal registration would produce more useful data.
`
`Drug Registries - Use and Limitations, Dr. Lewis Holmes, Chief, Genetics and Teratology
`Unit, Pediatric Service, Massachusetts General Hospital
`
`The recent development of numerous registries for various uses, shows that we have finally
`reached some consensus that prospective pregnancy registries make sense. Registries for
`
`Acyclovir, Varivax®i Anti-retroviral Agents, Sumatriptan registries are all industry based. The
`Acyclovir registry was established in 1984 in response to the concern that it could be a human
`
`2
`
`CFAD VI 1014-0006
`
`

`
`teratogen. It now contains data from over 600 pregnancies, and shows no major defects; for
`Surnatriptan, 128 pregnancies, with no significant defects; Varivax®, 62 pregnancies, with no
`significant defects.
`
`AED Pregnancy Registry (Toll free# 888-233-2334)
`
`The registry was formed to assess fetal risk from all AEDs in pregnancy. The registry staff is
`multi-dimensional, including teratologists, epidemiologists, epilepsy specialists, R."Ns, MPHs,
`biostatisticians, etc. The registry is supported by six manufacturers of anti-epileptic drugs
`(AEDs). A woman calls the registry, is asked for consent, has an initial interview, receives a
`follow-up call at seven months into the gestational process, and a follow-up postpartum. Adverse
`events are reported to the manufacturer who must notify the FDA promptly. The Scientific
`Advisory Group will decide when the findings are appropriate for presentation at medical
`meetings and for publication. A control group will also be recruited.
`
`The issues raised by registries are: how to advertise the registries existence; consent forms; active
`interview vs passive reporting; and having corroborating information on the exposed infant.
`
`Q&A
`
`Dr. James Buehler, CDC: Only 80 women enrolled in the anti-retroviral registry is a small
`number, which causes concern. HIV-infected women are disproportionately members of
`economically or socially disadvantaged groups. Pregnancy is common among IDV-infected
`women. Special efforts may be needed to inform them about the hazards of thalidomide and
`enroll them in birth defects prevention programs if they are taking thalidomide for treatment of
`mv disease.
`
`Dr. Holmes: We recently completed a project in which over 500 women who took AED during
`pregnancy were recruited. Those who did not enroII were more likely to be poor, single, less
`well-educated and from minority groups. This group will be hard to enroll in a Pregnancy
`Registry. We can reach some people through foundations, e.g., the Epilepsy Foundation, but will
`not do well in recruiting this less well-educated and well-informed group.
`
`Dr. Alice White, Glaxo Wellcome, Inc.: The Antiretroviral Registry enrolled 95 women
`exposed to AZT in their frrst trimester, 260 in all. Pharmaceutical companies can't promote
`drugs in pregnancy, so we haven't done an effective job in publicizing the pregnancy registry.
`Another problem we face is the shift to combination therapy.
`
`Ms. Jeanne Manson, Merck Research Labs: With the V ARIV AX Pregnancy Registry, we
`have contacted organizations involved in maternal and child health care in the public sector that
`have advertised the registry in their newsletters. It has not been possible to determine how
`effective this is in stimulating reporting, but it is feasible to advertise in the public sector. It is
`also possible to utilize the marketing/promotional efforts put into place by the manufacrurers to
`
`3
`
`CFAD VI 1014-0007
`
`

`
`advertise registries. For example, with V ARIV AX. every shipment of vaccine to physicians
`contains a card advertising the registry. Also, with registries that are dependent upon voluntary
`reponing of exposed pregnancies, it is important ot offer incentives. Health care. providers who
`are volunteering their time to report cases have to be offered something that is useful to them in
`providing information/care to their patients. For example, with the V ARIV .AX Pregnancy
`Registry we mail all health care providers who contribute data to the registry an annual report
`summarizing findings to date.
`
`Dr. David Erickson, CDC: The major purpose of the registry is to define the teratogenity of
`drugs. With Accutane this was not true, so how do these registries fit in?
`
`Dr. Holmes: The motivation for companies is that they have drugs ready for the market. Will
`this new generation of drugs include some with no fetal effects?
`
`Ms. Sally Cooper, Executive Director, PWA Health Group: The AED registry is not well
`known. We need to figure out how to market the registry.
`
`Dr. Holmes: Let non-public agencies do it.
`
`Dr. Paul Fernhoff, Associate Professor of Pediatrics, Emory University School of Medicine:
`Registries stops collecting information after the birth.
`
`Dr. Holmes: It is an issue of money. If a lot of calls come in, we can't keep up the rigor
`described.
`
`Contraception Efficacy~ Dr. Elizabeth Raymond, Associate Medical Director, Family
`Health International
`
`The effectiveness of various methods of contraception depends on how often they are used, the
`difficulty of use, the costs of the contraceptive, the side effects caused and how willing women
`are to live with those side effects. As shown in the following table, the possibility of pregnancy
`during the first year of use varies among methods, and between "typical" use and "perfect" use,
`with perfect use being difficult to measure. First year statistics are given since people who fail
`with a particular birth control method tend to fail early in its use. It is important to point out that
`these statistics may not apply to women using thalidomide, due to the level of compliance, the
`frequency and timing of intercourse, and the fecundity of the couple.
`
`4
`
`CFAD VI 1014-0008
`
`

`
`Probability of Pregnancy During the First Year of Use
`
`Method
`Pills
`combined
`progestin-only
`
`DepoProvera®
`
`Norplant®
`
`run
`(10 year use)
`TCu 380A
`Progestasert® (1 year use)
`
`Sterilization
`female
`male
`
`Condom
`male
`female
`
`Diaphragm with spermicide
`
`Cervical cap with spermicide
`nulliparous
`parous
`
`Sponge
`nulliparous
`parous
`
`Spermicide
`
`Periodic abstinence
`
`Withdrawal
`
`% pregnant in first year
`typical use
`perfect use
`3
`
`0.1
`0.5
`
`0.3
`
`0.09
`
`0.6
`1.5
`
`0.4
`0.10
`
`3
`5
`
`6
`
`9
`26
`
`9
`20
`
`6
`
`1-9
`
`4
`
`0.3
`
`0.09
`
`0.8
`2.0
`
`0.4
`0.15
`
`12
`21
`
`18
`
`18
`36
`
`18
`36
`
`21
`
`20
`
`19
`
`85
`Chance
`Emergency contraceptive pills reduce the risk of pregnancy by 75%.
`Lactational amenorrhea is a highly effective, temporary method of contraception.
`
`5
`
`CFAD VI 1014-0009
`
`

`
`Adapted from Hatcher et al, Contnceptive Technology, 16th edition, Table 27-l
`
`The pregnancy rate of the women in the Accutane study was low. The survey found that among
`women using various methods of contraception, fewer pregnancies occurred than were expected,
`which is undoubtedly due to the high education and motivation of the patients leading to a high
`1evel of compliance. In addition, other factors such as lm,· coital frequency may also have played
`a role.
`
`One issue raised at another Thalidomide conference, is the time-to-effectiveness of the
`contraceptive method used. With hormonal methods the time-to-effectiveness is said to be seven
`days or less if the method is initiated at the recommended time in the cycle, and for barrier
`methods and female sterilization it is immediate. To date, there is no good data on the time-to(cid:173)
`effectiveness for male sterilization. The real issue, however, is not time-to-effectiveness, but how
`long it takes a woman to get used to the method chosen, and how well she uses that method.
`Drug interactions with contraceptives is also a problem~ since some. drugs reduce the
`effectiveness of contraceptives. Of course, a major issue is the woman's willingness, or policy
`makers' willingness, to offer abortion as an option to women whose fetuses have been exposed to
`human teratogens.
`
`Q&A
`
`Ms. Sandy Gangen, TeratoJogy Information Services of Western New York: This goes
`beyond educating women about their contraception options. We need to educate women about
`themselves. Physicians need to talk about what ovulation is, and when it occurs. Fewer accidents
`will occur when women understand how their bodies work and how contraception fits into the
`picture.
`
`Dr. Raymond: That's right. We see the same in the women we work with.
`
`Dr. McDonough: The FDA has made recommendations on emergency contraception, but
`companies will not advertise them because ofliability risk. In addition, the Princeton data we
`saw in Dr. Raymond's presentation shows contraceptive efficacy as equivalent in mini-progestins
`and combination oral contraceptives. This is contrary to all published studies, where mini~
`progestins are consistently second best. Also, we are assuming DepoProvera® is 100% effective,
`but in typical use some patients don't show up for the follow-up injections.
`
`Dr. Raymond: The FDA approved use of several pill brands for use as emergency contraception.
`All the regimens contain the same hormones but have slightly different doses. Just because drug
`companies won't advertise emergency contraception doesn't mean that others can't advertise it.
`Planned Parenthood is planning to advertise emergency contraception. DepoProvera® is very
`forgiving of incorrect use in that it is effective for longer than the recommended 13 weeks, so a
`short delay in the interval between injections is unlikely to compromise effectiveness
`substantially. We don't have very much data yet on the use of the progestin-only pills for
`
`6
`
`CFAD VI 1014-0010
`
`

`
`emergency contraception.
`
`Dr. Erickson: Dual methods may be more effective, say a barrier method plus a spennicide.
`The Roche material says you must use two methods, and the FDA specifies two in its materials.
`However, does it make sense for DepoProvera® users to use a spermicide too? Despite Roche's
`advice, most women didn1t use two methods, did they?
`
`Dr. Raymond: The Accutane pregnancy prevention program requires two effective forms of
`birth control, but I agree with you: if a woman is using DepoProvera® or Norplant® there is no
`need to add a condom. If she is using only a barrier method, however, it is a different story. A
`second method in that case can make a big difference in pregnancy rates.
`
`Dr. Mitchell: We did ask about two methods and found that there were so many combinations,
`the information was hard to classify. IfDepoProvera® and Norplant® are the most effective
`methods, and they are reversible, are you seeing as little as we are?
`
`Dr. Raymond: Norplant® was more popular several years ago than it is now, largely due to
`publicity about its adverse effects, which is probably mostly unfounded. DepoProvera® is being
`used more, but its side effects such as bleeding abnormalities are not acceptable to some women.
`
`Ms. Manson: How were the perfect use figures calculated?
`
`Dr. Raymond: They were taken from Dr. Trussell's data, and come from different sources. I
`think most of them are from clinical trials that were monitored, but are probably not
`representative of the general population. The withdrawal figures are a guess.
`
`Measures to Help Ensure Appropriate Use - Debra Birnkrant, Food and Drug
`Administration
`
`In 1993 the Guidelines for Use of Women in Clinical Trials were revised to allow women to
`enroll in clinical trials. Since women of childbearing age were not previously allowed to
`participate unless they had a serious or life-threatening disease, there is very little information on
`women and drugs. It is believed that pregnancy testing and education of women who wish to
`participate in drug trials could help to reduce fetal exposure to harmful substances during testing.
`The FDA is looking at two ways to reduce the risk of adverse fetal exposure through the
`Pregnancy Labeling Task Force and the Pregnancy Registry Working Group.
`
`The goal of the Pregnancy Labeling Task Force is updating the Pregnancy Usage section of drug
`labeling to describe the known and possible effects of a drug in pregnant women and on fetal
`development. The Pregnancy Registry Working Group is exploring the use of a registry for
`women who participate in clinical trials and for women who are prescribed certain medications,
`so that data from human exposure canb be assessed and also incorporated into labeling of drug
`
`7
`
`CFAD VI 1014-0011
`
`

`
`products.
`
`A third FDA initiative, the Thalidomide Working Group is looking at ways to help to ensure
`consistent practice for the safe use of thalidomide. These methods include: an accounting of all
`usage of thalidomide; requiring an informed consent document to be signed by all subjects who
`receive thalidomide; distribution of an informational patient brochure; and a database of all
`patients who take thalidomide. It is unusual to have a working group for a particular product, but
`this drug is reviewed for a multitude of indications in multiple divisions, and the FDA wanted to
`be sure the drug was used consistently and examined thoroughly. The informed consent form
`details the birth defects caused by thalidomide, as well as other side effects of the drug. The fonn
`also describes birth control measures that should be used by men and women taking the drug. It
`has been agreed by the working group that all women of childbearing age, unless they have had a
`hysterectomy, should be tested for pregnancy prior to being given thalidomide. This information
`is included in the consent form and in the patient information brochure, from which we borrowed
`(with permission) Roche's idea of the "no pregnancy" symbol.
`
`A risk/benefit analysis must be conducted for each woman before she takes thalidomide. Of the
`59 who received thalidomide in our database, most of whom were of childbearing age and in
`advanced stages of disease, 55% had been sterilized and 32% were abstinent.
`
`The FDA is also looking at various methods of helping to ensure the safe use of thalidomide by
`reviewing the ways other drugs with important side effects are handled, for example:
`
`D
`0
`0
`D
`D
`0
`
`restricted distribution (Fentanyl, Oralet)
`limited quantity (Clorazil)
`consent (Accutane, Felbatol)
`laboratory testing (Clozaril/ requiring a white blood count)
`registry (AZT, Acyclovir)
`patient/provider education (Accutane)
`
`In addition, whenever a marketing application is submitted to the Agency, it will be presented
`before an advisory committee. Finally, helping to ensure the safe use of thalidomide is a
`cooperative effort among the Public Health Service, the pharmaceutical industry, health care
`providers, and consumers.
`
`Q&A
`
`Dr. J.M. Friedman, BC Children's Hospital: Would the precedent set by the restrictions for
`controlled substances be used for thalidomide?
`
`Dr. Birnkrant: Some drugs such as Fentanyl are restricted to specialists only. With HIV,
`however, patients are not treated by just one specialty, but by many physicians.
`
`8
`
`CFAD VI 1014-0012
`
`

`
`Dr. Friedman: That's my point, why not handle it like narcotics?
`
`Dr. Birnkrant: That1s a good point, that's why it is important to have these meetings.
`
`Dr. Thomas Sinks, CDC: There is a new generation of doctors who may not know about
`thalidomide. Rather than deal with thalidomide from a safety perspective, maybe we should use a
`hazard perspective.
`
`Ms. Cooper: Other teratogens are available, so I'm glad to see the FDA's concern. What about
`the other drugs? What about a group for these drugs?
`
`Dr. Birnkrant: The initiatives we are looking at include updating the pregnancy section of the
`patient information labels, and whether pregnancy registries are a possibility.
`
`Dr. Manson: Non-teratogenic analogues of thalidomide have been identified, and structures
`published. Are there any efforts being made to determine if these non-teratogenic analogues
`have efficacy for the clinical indications being evaluated?
`
`Dr. Birnkrant: We want analogues that provide benefit without the side effects. Celgene
`Corporation is represented here today, and they are conducting research on the development of
`thalidomide analogues.
`
`Dr. Mitchell: The Clozaril model is not a bad one to consider. Not any phannacist can dispense
`it. The phannacist must be registered. This is obviously labor intensive, and therefore,
`pharmacists are not happy about the procedure. Also, the doctor must show that a white count
`has been performed before the patient can get a supply of the drug.
`
`Ms. Susan Winckler, American Pharmaceutical Association: Pharmacists are pleased with
`this system. There was an earlier concern that they would have no access to the drug.
`
`Dr. McDonough: The FDA could provide an incentive. for isolating a single active isomer,
`which will not have the teratogenic effects.
`
`Dr. Birnkrant: The FDA would encourage development in this area of research.
`
`Ms. Manson: There have been published structures of thalidomide which have. greater (EM12)
`or lesser (EM87) teratogenic activity than thalidomide itself [Bazzoli et al., J. Embryol. Exp.
`Morph. 41: 125·135, 1997]. The extent to which these analogues have been evaluated for
`efficacy in the variety of indications being pursued is not clear. It should be possible to work out
`structure-activity relationships for these parameters. The most feasible approach today is to
`expend basic research efforts to identify non·teratogenic analogues of thalidomide.
`
`Dr. Birnkrant: The interaction between oral contraceptives and thalidomide was studied by the
`
`9
`
`CFAD VI 1014-0013
`
`

`
`FDA. Preliminary results show that the levels of the active components of the oral contraceptive
`are the same in the presence and absence of thalidomide. This is very encouraging.
`
`Dr. Erickson: The FDA Advisory Committee reviews applications for the use of thalidomide
`and other teratogens. Could the agency do more? Could the agency have continuing oversight
`performed by outside group?
`
`Dr. Bimkrant: Through the accelerated approval process the Agency has the ability for
`continuing oversight. That type of approval would restrict distribution if it is deemed that the
`drug cannot be used safely without restricting its use by physician, quantity dispensed, pregnancy
`test, etc. We can also monitor the advertising of the drug.
`
`Dr. Oakley: We are not talking about safe. use, but rather about reducing the risk. Safe means
`absolute.
`
`Dr. White: We have talked about a pregnancy registry, but there are different kinds of registries
`with different purposes; some are hypothetical, generating designs, and some are identified by
`issue. We need to answer what drives the registry before it is implemented. That answer will
`determine how long the registry is in use, what questions need to be asked, etc.
`
`Ms. Rashmi Deshpande, Bristol-Myers Squibb Co.: What about control during
`manufacturing? Do you ever reach serum concentrations [that would be dangerous] for the
`people working there? Aie women who work in the factories informed?
`
`Dr. Birnkrant: The drug is being manufacturured WJder appropriate conditions and with
`appropriate controls. Also, the U.S. is not the only place where thalidomide is used. We are
`contacting other countries for their ideas.
`
`Ethical Issues - Dr. Kathleen Kinlaw, Associate Director, Center for Ethics in Public Policy
`and Professions, Emory University
`First I will provide an outline of the maternal/fetal relationship, and second a look at the drug
`approval process using the formal rule of justice implications for distinctions between
`thalidomide and other teratogenic medications.
`
`The maternal/fetal relationship and perceptions of conflict of interest is an old question and
`conversation, often discussed in clinical ethics realms. Similar to the discussion in these clinical
`situations, the question of responsibilities to the woman and fetus in research and therapeutic
`medication use, can be discussed using three primary positions. These three positions might be
`characterized by:
`
`(I)
`(2)
`
`the priority of the woman in decision-making;
`the priority of the fetus in decision making; or
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`(3)
`
`no abso]u.te prioritization but rather the independence and perhaps
`interdependence of the woman and fetus in decision making.
`
`According to the first position, the woman's autonomous right to make decisions is of primary
`value. The woman represents a fully human, prior-existing individual who has full moral status
`to make decisions surrounding her care. Thus she is presumed both capable and to be trusted in
`decisions about whether to participate in a thalidomide trial, whether she is of child-bearing age
`or not. According to this position, the right of an individual to control her body is essential to
`human well-being. A woman's biological fenility does not override or diminish in any way her
`bodily integrity.
`
`For some proponents of this position, the fetus may not be seen as having equal moral status with
`the woman, with the fetus's interests or claims as secondary to that of the pregnant woman and
`her autonomous right to control her own body. In keeping with this position the woman should,
`of course, be fully informed and supported in her decision making process, but should not
`categorically be eliminated from participation in medication trials nor systematically told not to
`use approved medications. This would be true for the pregnant woman assessing the therapeutic
`benefit for herself of taking a medication that poses teratogenic risks for the fetus. Providing full
`information about the risks and information about alternatives for treatment or symptom relief
`would be important for the pregnant woman to weigh risks and benefits. Government
`intervention in the decision process, other than to inform, is inappropriate in this position.
`Proponents feel that this stance is essentia1 to sustaining the trust relat1onship between health
`professionals and the woman receiving medication.
`
`A second position places the fems as prior in the decision making process. According to this
`position, life begins at conception and thus the fetus is a full person. The value of human life is
`supreme. Human life at any point along the continuum of development is seen as having
`intrinsic value. No other value, including respect for the woman's autonomy, is commensurate
`with respect for human life. Therefore, in the pregnant woman there is no absolute right of the
`woman to control her own body. The woman's body is no longer a single unit and decisions
`made must incorporate the rights of the fetus.
`
`Thus, proponents of this position woutd welcome and value governmental intervention in the
`role of advocate. for the fetus. Forced c sections, incarceration of cocaine-abusing pregnant
`women, and laws restricting abortion might all be justified by this position. Proponents of this
`position would support strongly written guidelines to avoid the possibility of a pregnant woman
`from ever taking thalidomide. They would also support either that thalidomide not be available
`to women of child-bearing age or that stringent rules be in place to avoid women of child-bearing
`age who are currently taking thalidomide from becoming pregnant. Oversight of contraceptive
`practices, regular pregnancy testing and clinical monitoring would likely be components of
`guidelines for this position. Woman in whom unintended exposure does occur would be
`provided support on dealing with resulting disabilities, but the option of abortion would not be
`acceptable due to the unconditional value and dignity of human life.
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`A third position does not assign an absolute priority in the relationship between the pregnant
`woman and fetus, but rather recognizes two cities who exist in interdependent relationship with
`each other.
`
`Most of the Obstetrics literature now refers to the fetus as a second patient due to such
`technological advances as high resolution ultrasound, fetal monitoring, and fetal therapy.
`However, identifying the fetus as a distinct patient sets up a potential conflict between the
`pregnant woman and the fetus based on the traditional medical assumption that medical decisions
`are made