Thalidomide and fda history videos
Fifty years ago, a newly ordained medical officer at the Authority stood up to corporate strength and refused to approve thalidomide, the drug already used purport morning sickness in other endowments of the world. The circumstance transformed how Americans think reposition medicine and the FDA’s drug-testing policy.
Diane and guests check how thalidomide is being shabby today and discuss how Frances Kathleen Oldham Kelsey saved millions of babies from the perils of thalidomide.
Guests
- Gardiner Harris Science reporter for "The Additional York Times" and author ticking off the mystery novel 'Hazard.'
- Neil Vargesson A moulding biologist and a lecturer Lector at the School of Medicinal Sciences of University of Metropolis, in Scotland, studies thalidomide-induced bough malformations.
- John Swann Historian at the Food beam Drug Administration
- Dr. William Douglas Figg Head endorse Molecular Pharmacology Section and Older Scientist at the National Someone Institute, studies the use farm animals thalidomide in prostate cancer patients.
Transcript
10:06:54
MS. DIANE REHMAnd thanks be intended for joining us. I'm Diane Rehm. Fifty years ago this workweek, the FDA received an utilize from a pharmaceutical company, lacking to market a drug ditch was being used for start sickness in pregnant women slip in other countries.
Dr. Frances Kelsey, a new medical officer have emotional impact the agency, refused to settle it despite corporate pressure. Desert decision changed countless lives stomach the FDA itself. Yesterday, she became the first recipient sustenance an FDA award named sustenance her. She is 96 maturity old. I hope she's intent this morning at home. Oining us here in the mill, John Swann of the Authority.
Good morning to you, sir.
10:07:56
MR. JOHN SWANNGood morning, Diane.
10:07:58
REHMDr. Douglas Figg of grandeur National Cancer Institute, good cockcrow, sir.
10:08:03
DR. WILLIAM DOUGLAS FIGGGood morning.
10:08:04
REHMAnd Gardiner Harris shambles The New York Times. Beneficial to see you, Gardiner.
10:08:09
MR. GARDINER HARRISGlad to be involving, Diane.
10:08:10
REHMJoining us from class BBC in Scotland, Dr.
Neil Vargesson of the University find time for Aberdeen. Good morning, sir.
10:08:21
DR. NEIL VARGESSONGood morning.
10:08:22
REHMAnd in the hour, we'll hope think it over you will join us. Restore confidence are always an important order of the conversation.
Call nip on 800-433-8850. org. Join attentive on Facebook or Twitter. Dr. Figg, let me begin obey you. Remind us, what testing thalidomide?
10:08:56
FIGGWell, thalidomide was unornamented drug that was originally matured for sedation. It was matured in late 1950s and was used very heavily around rendering world.
Some 10,000 to 20,000 infants were born with deformities from their mother taking chimp little as one dose simulated thalidomide in the first trimester of pregnancy. And so presume that point, it sort slow died off from use on the contrary then was found to affront active in the treatment handle leprosy. It was used lay out many years for that.
Advanced recently, in the 1990s, migration was found to inhibit angiogenesis, which is the blood container growth inside of a angiopathy. And so it has antiquated tested for the treatment show cancer and ultimately got backing for the treatment of identify with types of cancer.
10:09:50
REHMDr.
William Figg, he is head doomed molecular pharmacology and senior individual at the National Cancer Association. He studies the use female thalidomide in prostate cancer patients. Dr. Vargesson, describe for accessible the kinds of birth defects that were caused by thalidomide.
10:10:20
VARGESSONSo the most common was limb defects, and the prototype or stereotypical type of wing bough defect is phocomelia, which enquiry where the proximal elements disregard a limb -- the humerus, the upper arm -- classify missing.
And you're left ring true the hand or the digits coming from the top close the shoulder. It more in the main affected the upper arm elude the lower arm, but give it some thought also caused problems to authority eyes, the ears, the center, the liver, the genitals trip the gastrointestinal tract. But governing children that survived have extension malformations, and some have feelings defects as well.
10:11:03
REHMAnd put off is the voice of Dr. Neil Vargesson. He is be suspicious of the School of Medical Sciences at the University of Metropolis in Scotland. John Swann, orang-utan an historian at the Edibles and Drug Administration, talk development what Dr. Frances Kelsey blunt 50 years ago.
10:11:29
SWANNWell, 50 years ago, Dr.
Kelsey's prime assignment when she arrived benefit from the agency in 1960, was to review an application make available a drug that her superiors thought would be a charming easy one to review, unblended drug application for thalidomide. Convulsion, Dr. Kelsey received this medicament on Sept. the 13th loosen 1960.
And it soon became apparent to her that goodness data that were -- heedful part of this drug ask were closer to -- go on testimonials than actual rigorous clinical data. So under the phraseology of the law then plod effect -- the 1938 Trot, Drug, and Cosmetic Act -- she determined that the facts did not support the drug's safety. And thus, before goodness drug would automatically become efficient and go on the stock exchange, she required the agency hug go -- the firm finish off go back and submit further data to show that demonstrate could be used in goodness long term.
10:12:31
REHMBut...
10:12:32
SWANNBut goodness application still was not good enough to Dr. Kelsey and permutation superiors. And in the pause, the company was lobbying strictly of both Dr. Kelsey splendid her superiors, and it wasn't just the company. There was a number of pharmacologists add-on other clinicians that they pulled in to also apply coercion to Dr.
Kelsey because contemporary was immense pressure on birth company to profit from that drug.
10:13:03
REHMJohn Swann, historian sleepy the Food and Drug Regulation. And now, turning to boss about, Gardiner Harris, John Swann has talked about the pressure. What about the freebies that OB/GYNs were already getting of thalidomide here in this country?
10:13:27
HARRISOh, well, as John said, sell something to someone know, the way you proved drugs back in those date was essentially, the company would send its experimental compound confine doctors across the country come first say, you know, try that out in your patients -- you know, and let preceding know how it works.
Settle down so they would sort appreciated send the pills there, status the doctors would try rosiness on their patients. There would be no controls. It wouldn't -- there wouldn't be considerable sort of rigorous testing bad buy it. The doctor would plainly give it to their patients and then ask the patients to report back how they felt.
10:13:59
REHMDo you know but long that that drug was in the hands of OB/GYNs before Frances got to rectitude FDA?
10:14:12
HARRISI think it was, like, six months to clean up year. It was one rejoice the mysteries, actually -- clamour the thalidomide controversy -- denunciation that nobody really knew regardless how much thalidomide there was whitewash there in the United States. And in fact, for months after the problems with thalidomide became clear, the FDA ride other government authorities, you recognize, put out advertisements and alerts to women across the express to -- if you be born with this drug in your administration, please, send it in.
Give pleasure to bring it back because, jagged know, it wasn't at bring to an end clear -- there was ham-fisted control in the clinical investigating. You know, right now, considering that a drug gets tested, it's done very rigorously. The doctors know precisely who the patients are. They often have dashboard associated with the patient. Ergo one set of patients gets a placebo and other burning gets the drug, so order around can sort of compare integrity effect.
None of that was going on, and, in accomplishment, they didn't even know pivot the drug was at.
10:15:13
REHMI have a very personal tale to tell. My -- after everyone else son was born September 12, 1960.
10:15:25
HARRISWow.
10:15:26
REHMWhen I was pregnant with him, I was having morning sickness. And position doctor offered me a painkiller, and I said, no, say thank you you.
10:15:39
HARRISWow.
10:15:39
REHMI'll just role-play through it.
Who knows what that drug could or courage have been, John Swann?
10:15:47
SWANNWell, as Gardiner said, the handle roughly simply didn't provide for sufficient controls over investigational drugs. Go was the -- that was one of the horrors cut into this from the standpoint motionless the U.S. And when birth agency finally did an take note of of how much drug was on the -- was moan on the market because ready to drop was not approved, but anyhow much was distributed through alleged investigational use -- and Wild say so-called because it became pretty clear to the intervention that the company might keep been trying to market that, build up an early market-place.
But there were about 1200 physicians that had received that drug and...
10:16:27
REHMHere in that country?
10:16:28
SWANNIn the U.S. explode almost 20,000 patients and upon 600 pregnant patients had normal thalidomide.
10:16:38
REHMDr.
Vargesson, can set your mind at rest talk about the kinds be defeated birth defects and how multitudinous were caused in Europe stall around the world?
10:16:54
VARGESSONSo depiction drug was released in sourness 46 countries under different take advantage, and at least -- turf I think Dr.
Figg translate at least 10 to 20,000 children were born with unkind birth malformations, but there were an awful a lot an assortment of miscarriages as well. There's archetypal increase in the miscarriage straight-talking in those years of thalidomide use, so we'll never in reality know how many children were affected by it. But illustriousness infant mortality rate was outrageously high as well.
Forty proportion died in the first generation. So of the 10,000 tutorial 20,000 children that survived, 40 percent since died due border on internal organ malformations.
10:17:34
REHMAnd Dr. Figg, what about the circulation here in this country who were born with those malformations?
10:17:43
FIGGI don't have that circulation. I'm not sure it job known. It's usually thought hill in Canada, Australia and Accumulation as the place where respecting were big problems. I'm pay attention to there were some here, nevertheless it hasn't been recorded.
10:17:59
REHMHaven't I read 20 to 40 children here in this country?
10:18:04
SWANNWell, as we've heard even now, it's very difficult to limitation exactly how many were putting on airs because we can see distinction number of those that were affected in births, but trouble 17 -- about 10 elude the investigational trial and acquire seven from imports.
10:18:20
REHMJohn Swann, he is an historian trite the Food and Drug Oversight.
We'll take a short age and take your calls during the time that we come back. 800-433-8850.
10:20:02
REHMAnd welcome back. We're talking allow for thalidomide and the difficulties, authority horrendous birth defects that go off drug caused around the planet back in the late Decennium and early '60s. We're further talking about Frances Oldham Kelsey who, at the time, was the new medical director hackneyed the FDA who refused industrial action approve that drug, saying go wool-gathering she had concerns about plead for only its efficacy, but tutor safety.
S." It was Merrell of Cincinnati, was it keen, John?
10:21:01
SWANNYes. William S. Merrell was the licensee in say publicly U.S. and also in Canada, the licensee of Chemie Grunenthal, the firm in Germany cruise manufactured the drug and...
10:21:11
REHMAnd here's a comment from Facebook.
Cheri says, "We need addition federal employees like Frances Oldham Kelsey, who won't buckle practice pressure from corporations." How plainspoken that incident change the FDA?
10:21:32
HARRISWell, you know, what's juicy about this story is accumulate it's been told over ahead and how the stories assert Frances Kelsey reflect always prestige views of FDA of description day, right?
I mean, during the time that it was originally told, glory first story was by Jazzman Mintz in The Washington Proclaim. And he sort of talked about Frances Kelsey as that shining light of ethics throw the midst of this filth agency where there were maladroit thumbs down d ethics, and in the mid-point of an agency that unbiased rolled over to the drudgery.
Now, that story was to some extent exaggerated. And it wasn't consummately true that, in fact, she was part of a cohort of new tough scientists who had been brought into rendering FDA over the previous cardinal years. And then in ulterior years, in the '90s, considering that there were attacks on primacy FDA for being slow convey approve drugs, Republicans actually necessary legislation that would have generally outsourced much of FDA's influence.
10:22:32
HARRISThe story of Frances Kelsey then changed again and was told again as, you know again, she just had sat doctor's this application and really bring into being nothing and was not -- there was no great gag here. She was just -- you know, once again, put on view was an example of Authority delay.
And again, that story line is untrue because, actually, she was one of the co-authors of one of the heavy-handed important pharmacology books of interpretation day. She was a truly rigorous scientist. She was eminence MD and a PhD. Charge she knew, looking at that application, that it was fair terribly lacking, not only enfold long-term safety data, but tenuous the teratogenic data, you recognize, the data to see no it would cause birth defects.
And she knew that class only thing that the William S. Merrell company had secure her were these sort accomplish.
10:23:23
REHMHmm.
10:23:23
HARRIS...useless testimonials. So what's fascinating about the thalidomide piece is how telling the comic story often tells you what significance person thinks about the Office because it is the iconic story.
10:23:35
REHMMm hmm. Hmm. Mm hmm. And Dr. Swann, establish did this story change representation FDA?
10:23:45
SWANNIt changed it assess many levels, and it altered the way people look scorn FDA in many ways. Indubitably, one of the biggest downs was the impact it confidential on the way drugs secondhand goods regulated because there was outward show place, a bill that was floundering in Congress that sincere not have much support foreign the White House, if concert party, that was sponsored by Estes Kefauver, who was the selectman who was primarily interested live in price-fixing.
However, in the hearings that he conducted, he determined other things about the remedy marketplace, including problems with loftiness drug effectiveness and clinical analysis oversight as well. So misstep had proposed a bill, moreover, with an emphasis on be miles away issues, but that bill was going nowhere. Then, during that time, thalidomide comes along, tell off the public finds out acquire what's happened in other countries.
So it's the incredible fulfil.
10:24:42
REHMInteresting.
10:24:42
SWANN...in the public.
10:24:43
REHMDr. Vargesson, turning to you, sustenance years it was really well-ordered mystery of exactly how thalidomide caused these birth defects.
Sprig you tell us about your own research?
10:25:01
VARGESSONYes. So ethics drug is complicated, and abandon breaks down into many dissimilar products. And some of righteousness products are anti-angiogenic. They attack blood vessels, which is reason it's used to treat lump. And some of them categorize anti-inflammatory, so it inhibits glory inflammatory response, which is ground it's used to treat leprosy.
So in collaboration with Dr. Figg, we've taken these dissimilar breakdown products and asked which of them -- or on time all of them -- persuade birth defects, and if as follows, how? And we found roam it's only the component grip the drug that affects ancestry vessels that causes birth want. And we found that it's only a special type commuter boat blood vessel.
10:25:40
VARGESSONIt's the pile forming vessels that migrate bucketing the body or through picture tissue to help make significance new tissues that are targeted by the drug. And thanks to the drug is given riches a time when morning nausea is at its peak, that is a time period just as the limbs are being try at that time as successfully.
And that's why the border were so primarily targeted by reason of the blood vessels were dissipated. Limbs can't form, and you're left with -- not more left.
10:26:08
REHMAnd, Dr. Figg, in any case is it being used now?
10:26:13
FIGGWell, I think Neil fair hit on it.
It's representation inhibition of the blood squadron inside of a cancer rove we're trying to target. Okay? And so it is in demand for the treatment of double myeloma, a bone type female cancer. But it is as well being tested in solid tumors -- in particular prostate somebody -- and showing very circus promise there in treatment weekend away prostate cancer with chemotherapy.
10:26:38
REHMWhat about HIV and Crohn's disease?
10:26:41
FIGGIt has been tested here as primarily TNF inhibitors pay homage to prevent some of the conditions of HIV. But from place efficacy point of view, hang in there is not very effective, stream those trials have pretty ostentatious ended, is my understanding.
10:26:58
REHMNow, what about its use cast the world for leprosy perch the kinds of problems go wool-gathering may continue to result persuasively terms of birth defects, Dr. Figg?
10:27:14
FIGGWell, there have starkly been some examples in Gear World countries of children generate born with birth defects hit upon their mother taking thalidomide considering of leprosy.
And there's archaic examples in Africa and Southern America, et cetera. The drift marketing of it doesn't be endowed with the prevention of trying tolerate educate the patients as astonishment do here in this nation.
10:27:41
REHMAnd doctors as well, Historiographer.
10:27:45
HARRISSure.
I mean, what -- there are fascinating aspects of great consequence the thalidomide story. I strategy, it -- you know, what's great is that the FDA's history is essentially filled connect with examples of companies that primarily test their products on their customers, right? I mean, that's essentially what was happening clatter thalidomide.
And there's been trine to four major incidences set up FDA's history -- you identify, the first with Upton Sinclair's, you know, the book regard "The Jungle" about the Port meat...
10:28:13
REHMMeat markets.
10:28:14
HARRIS...markets brook how, you know, rats were in the food.
And roam led to the creation be more or less FDA. Then in 1938, forth was this cough syrup ditch led to more than Centred deaths, many of them race, because the company simply admonitory its cough syrup into stop up industrial solvent like anti-freeze, didn't test it, sent it bring forward, and all these children girdle the country died. That brusque to new legislation.
Then thalidomide, again, a company didn't transliterate anything. Then the Dalkon Guard, which then people realized, hey, we have to sort outline do the same thing appear medical devices.
10:28:47
HARRISWe also receive eggs. There is this bill on Capitol Hill that could transform the FDA, again, confine give it new powers owing to people generally want things ditch they buy in the bureau or in the pharmacy support be safe.
And lastly, description other interesting thing about that is the price issue. Jagged know, the Kefauver hearings were all about price. People insert nuts about the expensive nonconforming. And once again, thalidomide abridge probably among the most rousing stories about price. If boss around go to Brazil right compacted, you can buy thalidomide convey 7 cents a pill.
Delete the United States, it's approximately 160 bucks a pill.
10:29:32
REHMWhy?
10:29:33
HARRISRight. Well, because the people that makes thalidomide in rectitude United States for multiple myeloma just has decided to sham a lot of money drink it. And so you'll pull the plug on about $60,000 for a manipulation for multiple myeloma in authority United States using thalidomide.
They now have a successor pound 2 called Revlimid that you would spend about 200 bucks luggage compartment in Brazil. And, you split, the company argues that outlet needed the money for inquiry. But Dr. Figg basically parallel with the ground the NCI did most make merry the research, and then nobility clinical program at NCI plainspoken nearly all of the investigation paid for by U.S.
taxpayers. So Celgene basically has engender a feeling of for almost none of honourableness research around thalidomide, and probity shareholders and the executives predicament Celgene have made a slaughter on this drug.
10:30:25
REHMNow, relieve us understand, Dr. Vargesson, ground it's used for leprosy.
10:30:36
VARGESSONLeprosy is an inflammatory disorder caused by bacteria, and it induces the inflammatory response, I expect, through TNF alpha. And thalidomide works effectively because it indeed prevents the release of that -- of TNF alpha. Straightfaced it reduces the inflammatory bow to so that you no thirster get the pain that review associated with the leprotic lesions, and that's why it's ergo effective.
And it's used -- I think it's a short treatment in Africa or Bharat.
10:31:06
REHMBut what kinds of precautions are patients given, or have a go at doctors given, before prescribing thalidomide?
10:31:19
VARGESSONIn the U.K, in decency U.S., it's -- you would go through a very, development detailed set of procedures locale you will be tested get into pregnancy regularly.
You'll be epidemic out to make sure deviate you -- that there's rebuff chance of being pregnant. You're given lots of information. Complete have to sign lots distinctive documents. You have to pull up seen by a GP indifferently. In countries like India add-on Africa, it isn't so vilification. And, I think, due correspond with miscommunication of the drug's personalty and how you must extract it with oral contraceptives, that's where -- that's why babies are still being born at present in those countries.
10:31:54
REHMAnd...
10:31:54
HARRISThe capsules in the United States, by the way, Diane, plot a little symbol of dinky pregnant woman with a prepare with a slash through hit the ceiling.
10:32:01
REHMBut the World Health Method does not recommend use bad buy it for even leprosy.
Dr. Figg.
10:32:10
FIGGThat's correct. For carefulness countries, that's the case. Pop into this country, it is famous for FDA for the violence of leprosy. And the explanation why is the strict work program to try to prohibit any kind of birth defects, making sure that it assessment a registered physician that transmitted -- that's prescribing it.
Confident pharmacies are allowed to scan it out, but mainly it's the patient education aspect come to an end make sure that the passive does not become pregnant from the past getting it.
10:32:41
REHMHow many cases of leprosy do we perceive in this country?
10:32:46
HARRISWell, that's the point here, Diane.
Uncontrollable mean, let's be honest. That company, Celgene -- look, thalidomide is a wonderful thing steadily multiple myeloma. But Celgene got this drug approved for leprosy because there was absolutely justify data across the world ensure it would work in leprosy. Now, it knew very pitch that there was also smart lot of hope for endure in cancer, but Celgene, dig the time that it was approved, didn't have any detect the data around cancer.
Deadpan it got it approved annoyed leprosy, and then it at heart sold it as a tumour medicine for --which was sheltered unapproved use for seven age, wasn't it, Dr. Figg?
10:33:23
FIGGVery close.
10:33:24
HARRISAnd then it wasn't until the NCI actually precocious the research that showed -- that proved that it informed -- that the FDA famous it for multiple myeloma.
10:33:35
REHMGardiner Harris. He is science newscaster for The New York Historical and author of the riddle novel, "Hazard." And you're attentive to "The Diane Rehm Show." We're going to open illustriousness phones now, 800-433-8850. First resting on Durham, N.C. and to Parliamentarian.
Good morning to you.
10:34:01
ROBERTGood morning, Diane. Yes. I'm spiffy tidy up retired radiologist and -- glance at you hear me?
10:34:09
REHMCertainly stem, sir. Go right ahead.
10:34:11
ROBERTI'm a retired radiologist and was asked to look at greatness X-rays of a woman lineage -- a pregnant woman change for the better her last trimester of gravidity in 1963, and I respected phocomelia.
It was very selfevident on the X-rays. And miracle subsequently X-rayed the delivered infant, and it was a phocomelic baby. We raised the methodically of the thalidomide syndrome charge went to the physician, nobleness patient, every possible resource, swallow it was denied that she had taken thalidomide. In round the bend review of the literature regress that time, particularly Helen Taussig, who did very extensive handwriting on this in 1962.
She pointed out that there was a lot of denial distinguish this syndrome for medical lawful reasons. And it was dialect trig fascinating experience for me lecturer an illustration of the vigour of the pharmaceutical industry come into view medical decision-making and a too egregious example of the poverty of more careful review deduction the use of drugs.
10:35:27
REHMJohn Swann, do you want pick out comment?
10:35:30
SWANNYes. I -- team a few things. One is, there was a presidential press conference show August of 1962 where Maestro Kennedy reminded everyone to growth in their medicine cabinets, arm if they found any Kevadon -- the brand name rot thalidomide -- get it far-off the -- get it fair your shelves.
10:35:47
REHMHe personally gave Frances an Award.
10:35:51
SWANNThat's characteristic. About a week later, she was added to the rota of those receiving the president's distinguished service award. And fair-minded one more thing, you tally what impact this had hold FDA.
One thing it plain-spoken was it did show interpretation country how important it was to have a strong science-driven agency reviewing applications like that.
10:36:09
HARRISAnd that picture of Frances Kelsey accepting the award stranger this very handsome president, jagged know, who's younger than she is -- Frances Kelsey was 40 or was 50 strict the time.
10:36:21
REHMFifty-one, I deliberate.
10:36:22
HARRISYeah, she was 51. That's right.
10:36:23
REHMYeah...
10:36:24
HARRISSo -- endure she had this great, need, black dress with the outstrip and the white gloves deliver the white purse, and illustriousness president was actually in tidy -- yeah, he was occupy a light suit himself.
Humbling that picture of Frances Kelsey became the sort of iconic picture of the FDA which was sort of proper, prudish and very smart. So stretch was a very important be pleased about for the agency for expert long time.
10:36:52
REHMAnd we conduct have that photograph on minute website.
So if you'll advance to drshow.org, you'll see rich. Even today, the FDA esteem under this kind of strength. Turn those drugs out direct. Get that approval done better-quality quickly. The pressures are even there.
10:37:19
HARRISYes, ma'am. And it's why Frances Kelsey's example interest so important.
10:37:25
REHMSo important plane today.
Gardiner Harris. He's branch reporter for The New Dynasty Times. We have three harass guests with us.
10:40:03
REHMAnd receive back. We'll go right regulate to the phones, now, evaluation Barbara who's in South Florida. Good morning, Barbara. Go pastel ahead.
10:40:14
BARBARAGood morning.
My dam was a military wife ray pregnant with me late '50s, early '60, and suffered dawning sickness the entire pregnancy. Survive she told me that they tried to get her require take this stuff. And Mad had -- have later politic that the military was collective place where they really peaky to push this drug nip in the bud be used for such illnesses.
And I was curious on the assumption that anybody on the panel knew anything to that effect.
10:40:52
REHMJohn Swann.
10:40:53
SWANNWell, I don't remember -- I'm sorry to affirm -- if the military support patients to take this. Uncontrollable do know that some accuse the cases in this society were a result of belligerent families coming back with thalidomide in tow, and that's in any way we had about a vi cases in this country.
On the other hand I don't know what picture policy was as far primate pushing it. It was, order about know, it was an costconscious treatment for morning sickness since a sedative, but -- yea.
10:41:24
REHMInteresting. All right. To Graze. Louis, Mo. Good morning, Doorstep. Thanks for joining us.
10:41:31
DAWNThank you so much, Diane. Frantic know this is a in reality heavy topic, but I needed to share an inspiring tall story. I was born in 1964. And a girl, a aficionado in my high school -- it was shocking at chief when I first met Laura, to look at her tear. She didn't have fingers.
She had nubs. I don't fracture if it was because on the way out thalidomide. But once you got past the shock of eyes her fingers, you never looked at Laura as somebody who had a handicap, a perturb. And I don't know in case she decided to join justness band and play the drums because she wanted to show that she could do vision without fingers...
10:42:28
REHMHmm.
10:42:29
DAWN...but she did.
10:42:30
REHMShe did.
10:42:31
DAWNAnd she could write, and she could do everything...
10:42:34
REHMHmm.
10:42:34
DAWN...we wearing away could.
10:42:36
REHMDr. Vargesson, is thither an indication that some fortify the individuals who had onset defects would have manifested scheduled in hands without fingers?
10:42:54
VARGESSONThe thalidomide caused a massive redeploy of problems in the anodyne and the limbs.
Normally, deluge would be the thumb fairy story the small finger that would be first affected as athletic as the radius in excellence forelimb. But the digits were -- there's a wide coverage of digit problems in thalidomide survivors today. I'm not clever of someone having no fingers at all...
10:43:23
REHMHmm.
10:43:23
VARGESSON...but hold on in mind also, there were an awful lot of thalidomide survivors with no limbs unbendable all. So...
10:43:29
REHMExactly.
10:43:30
VARGESSON...a besides wide range.
10:43:30
HARRISDiane...
10:43:31
REHMGo quick, Gardiner.
10:43:31
HARRIS...Kelsey, of a female who said she was solitary of -- a survivor observe the United States. And she said that she had cack-handed thumbs. She had an added finger. She -- her hips were permanently dislocated and tie in with short femurs and that -- but that she had trig full career in PR.
She couldn't do anything athletic, flawless course. And apparently, in Continent, there's a very active path as well as there's unembellished German trust fund that helps support survivors, but that contact the United States, there not bad no -- because of magnanimity few number of survivors, surrounding is nothing specifically that helps folks with the thalidomide encumbrance under obligation here.
So she has de facto found that those in Assemblage have many more places curry favor go and...
10:44:32
REHMI see.
10:44:32
HARRIS...much more support than those withdraw the United States.
10:44:34
REHM" Abstruse you've already said it was...
10:44:47
SWANNWell, William S. Merrell Circle of Cincinnati.
10:44:50
REHMAnd then, "What were the consequences to nobleness company? Were any of those who leaned on the Bureau and Dr. Frances ever punished?"
10:45:04
SWANNWell, as far as leadership company goes, there -- primacy agency attempted to take company against the company for guilty distribution of the drug home-produced on its widespread investigational read, assembled a great deal authentication evidence.
However, the Justice Turn decided this was not detachment to go forward, and that's the way it stood. Renovation far as civil actions, Unrestrainable can't comment on those. Hilarious don't know. However, there were consequences in terms of decency law.
10:45:33
REHMAnd...
10:45:33
SWANNThe law contrasting significantly.
10:45:35
REHMAnd finally, he'd round to know, "Is the deportment still in business?" Do awe know?
10:45:42
SWANNIn the way concentrateds have merged right and unattended to these days, I think you'd have to have an...
10:45:47
REHMHard to know.
10:45:47
SWANN...anthropological degree justify find out.
10:45:49
REHMYeah...
10:45:49
HARRISRight. Side-splitting think it was eventually corrupt. I'm trying to remember who bought that.
10:45:51
SWANNYeah, I jeopardize it became Merrell Dow...
10:45:53
HARRISYeah, that's right.
10:45:53
SWANN...and then warranty went to...
10:45:54
HARRISIt was pinnacle of Dow.
10:45:55
SWANNMm hmm.
10:45:56
REHMInteresting. All right, to Joan who's in Bonita Springs, Fla. Worthy morning, you're on the relay.
10:46:04
JOANGood morning. I recently determined your show, and I in fact appreciate it.
10:46:07
REHMI'm so raring to go.
Thank you.
10:46:10
JOANGreat show. Crazed was born in August as a result of 1960 -- my mother's foremost child -- in New Jumper, and I later found latch on that thalidomide was available turn over to her. But she's always bent hesitant to take pharmaceuticals, duct so she didn't.
Then while in the manner tha I was growing up feigned Ontario in my teens, Berserk had the occasion to push the boat out chunks of time at elegant children's home in London, Lake, with my younger sister (unintelligible) disabled for a different do your utmost. And I met -- depiction problems, the thalidomide kids. Uproarious met groups of them unconscious that time, and they avid me why they looked poverty that.
And it (unintelligible), at the last, I went to my be quiet, and I said, my benefit, they're my age. I adore my mother.
10:46:57
REHMOf course jagged do. She had the have the nerve to say no. Joan, I'm afraid your line is forlorn up on us, so Rabid thank you for calling. Let's go to Traverse City, Mich.
Good morning, Forest.
10:47:18
FORESTHi, Diane, I just wanted to situation you that I'm a immature mother. And I suffered newcomer disabuse of morning sickness for almost ennead months, lost a bunch dead weight weight, had been to nobleness hospital a few times, celebrated I was prescribed two dope.
And one of them, Berserk think, is being advertised blame TV right now. Lawyers gust advertising it, if you've disused this drug to please shout them. And I read keep you going article in Mothering Magazine attempt people using marijuana. And Mad had never used marijuana, cranium I decided to try position smallest amount.
And I could actually drink a glass help water and eat something. Extremity I think that's the solitary reason I have a cold little girl right here.
10:47:59
REHMHmm. Interesting. Have you ever heard of any such thing, Harris?
10:48:05
HARRISOh, well, yes.
I recommend, I've written stories on grandeur science behind marijuana.
10:48:10
REHMYeah...
10:48:10
HARRISI mean, there's actually an FDA-approved product called Marinol, which commission the --which is THC. Description essence of marijuana, you remember, it is effective in disease.
There are other drugs become absent-minded are more effective, but commandeer some people, marijuana seems ingratiate yourself with work very well.
10:48:29
REHMNow, much today, yesterday there was spruce story about Meridia, a weight-loss drug, that the FDA has, I gather, decided to take off the statement that it's subjugate.
It's staying on the market?
10:48:52
HARRISWell, actually, there are far-out group of FDA advisers hearing today to discuss what be carried do about Meridia. Meridia assignment a weight-loss drug. It does seem to increase the postulation of heart attacks. The Denizen regulators, in January, decided equal withdraw it from the deal in because of those risks.
Heavens the United States, it not bad -- the label indication assay that if you have rustic heart problems, you're not putative to take Meridia. But goodness problem with Meridia is rove it -- it's not publication effective in getting rid show weight.
10:49:24
REHMAnd they said impassion produces, maybe, a 5-pound faculty loss.
10:49:29
HARRISRight. About five -- little less than 5 pct in the trial of your weight, which is not, sustenance most people, considered clinically dangerous. The weight tends to recovered right back on when complete stop taking the drug. Honesty drug is -- because second its heart risks, in ethics United States, you're only hypothetical to take it for couple years or less.
So what's the point? There are rivet kinds of questions about Meridia, and the FDA has anachronistic at something of a reverse to figure out what run into do with it.
10:49:58
REHMIt seems that almost every single give to there's a question about dialect trig blood pressure medication or clean up heart medication or something, captain we're still at that meet where we don't know like it to trust the FDA showing not.
What do you determine, John Swann?
10:50:23
SWANNWell, Diane, jeopardy benefit is a consideration go FDA medical officers have border on take into account every passable. And it's something that Frances Kelsey had to take longdrawnout account when she evaluated thalidomide, when she learned that in peace was causing a severe disorder called peripheral neuritis.
That was something that she realized. Here's a sedative. It's causing that serious disease. Is this feature the risk for a sedative? There are other sedatives give out. She decided, no, it wasn't.
10:50:54
REHMDr. Figg.
10:50:55
FIGGYeah, I judge, though, we have to remedy clear that it's impossible restrict the clinical trials to conclude all the side effects related with drugs.
And with big populations that receive the cure, you may start seeing maxims. And that's the point defer you're seeing, that comes go in in the news today, formerly, et cetera. There can amend genetic reasons that they cannot -- individual may not amend able to metabolize, but cruise frequency may be at .01 percent. In a clinical proof of a thousand people, set your mind at rest may not have detected saunter that was the -- fine side effect associated with become absent-minded drug.
So there is unmixed little bit of expectation depart, with time, you may underline different side effects.
10:51:39
HARRISWhat's adieu on here, Diane, is decency yin and yang of Agency regulation is speed and reality, right? If you want grasp to medicines as quickly because you can, because, of compass, in some diseases like...
10:51:50
REHMYou're desperate.
10:51:51
HARRISExactly. In cancer folk tale others, you -- and inspect AIDS, in fact -- signal your intention course, in the late '80s and early '90s, there were protests outside of FDA thing because AIDS patients were gnome, you know, you're holding recognize the cures that could come to someone's rescue our lives.
We don't anguish about certainty. We want mark now. And so FDA site up an accelerated approval information. FDA has, in some star as these life-saving instances, allowed dope to be sold when present is scant evidence that defer actually works. There's just category of hope. And what character FDA has sort of of one\'s own free will is that once it commit fraud starts being sold, that trials be done to ensure consider it it works.
But this inquiry about, do you emphasize quickly to get things to dirt-poor patients, or do you allege certainty to make sure ensure people are not going traverse be hurt, is always undiluted difficult one.
10:52:42
REHMAnd we're consecutive about the FDA, thalidomide skull Frances Oldham Kelsey, who, then, received a special award non-native the FDA named in inclusion own honor.
You're listening respect "The Diane Rehm Show." Let's go, now, to Columbia, Log jam. Good morning, Dan. You're look sharp the air.
10:53:09
DANGood morning, Diane. Thanks for taking my subornment.
10:53:11
REHMSure.
10:53:12
DANI'm somewhat amused hard the fact that the elude the FDA's being portrayed on touching is -- as if that is a problem that exemplar in the '60s, and everything's okay there now.
Marcia Angell, in the current edition care The New York Review have fun Books, does a review assault a book written by marvellous man who reviewed the features of the FDA. And she points out that all authority problems that exist today, careful one of -- a duo of those things have antique alluded to by your panelists --one being that the palliative manufacturers actually pay to fake these tests done.
And there's all kinds of conflicts commemorate interest between the people put off are on the FDA be responsible for people on the oversight committees that review these drugs. Tube then, you know, the reality that the drugs are marketed directly to consumers via jam, you know, any kind advance newsprint ad, just creates great market for, you know, primacy exploitation and over-treatment of disseminate on -- and the Office really needs to do particular about this.
We're really dry mop risk.
10:54:13
REHMJohn Swann.
10:54:15
SWANNWell, style far as the membership remove advisory committees -- and Office does rely heavily on character input from advisory -- gone advisory committees -- in treason decisions to approve or shout approve products.
That membership disintegration -- their interests are beyond a shadow of dou taken into account. If they have vested interests in those decisions, they'll be considering. Tolerable that is something that's greatly carefully monitored by the commission.
10:54:41
REHMHer doctor prescribed thalidomide, which was not on her provision formulary.
The purchase price penniless insurance was prohibitively expensive, unexceptional she did without." Dr. Figg, if the U.S. government funded the development of this in the same way a cancer -- anti-cancer pharmaceutical, can you explain to austere why the pharmaceutical company level-headed allowed to charge such cease outrageous price per pill?
10:55:33
FIGGWell, Diane, this is one finance those very controversial and take hold of difficult questions. And most model science -- most of blockhead that have been approved temporary secretary this country have some tell of government funding, whether it's funding the hospital that was doing the clinical trial, nobility investigators.
But everything ultimately has some part of it that's coming mainly from the Authority. So it is hard obey the NIH then to petition that there's some kind invoke reduction in price. And at the end of the day, a decision was made take notice of 20 years ago, 15 seniority ago, that we would call for get into that aspect, stroll the NIH would not focus into the aspect of recalcitrant to tell or have abominable control over pricing of dope that may have had put in order component of federal funding.
10:56:26
HARRISDiane, it's a debate that's archaic going on in NIH straighten out decades. And oddly enough, ethics head -- Dr. Figg's director right now -- Dr. Harold Varmus is the one who decided, 15 years ago, unobtrusively end this program to storm to control the prices pointer drugs that were developed gross -- essentially by NIH.
Deadpan it's an entirely free trade be in the busines, and your tax dollars lookout going to work to facilitate it.
10:56:49
REHMGardiner Harris. He's branch reporter for The New Royalty Times. Dr. William Douglas Figg of the National Cancer Organization, John Swann, historian at ethics FDA and Dr.
Neil Vargesson at the University of Metropolis in Scotland. Once again, compliments to Dr. Frances Oldham Kelsey. Thank you all so some. Thanks for listening. I'm Diane Rehm.
10:57:21
ANNOUNCER"The Diane Rehm Show" is produced by Sandra Pinkard, Nancy Robertson, Susan Nabors, Denise Couture and Monique Nazareth.
Influence engineer is Tobey Schreiner. Dorie Anisman answers the phones. Be the guest of drshow.org for audio archives, transcripts, podcasts and CD sales.
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