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High-dose retinol associated with birth defects
Biotech’s winning ways
on
action at all until early next year, but indibiotech’s growing prowess as a lobby-
Capitol Hill
The US biotechnology industry is considered a crown jewel of American innovation, even if the promise has yet to be fully realised. But the potential is so alluring that biotech companies still attract amounts of investment capital and states have bent over backwards extending tax breaks to firms looking for a place to call home. The perception of biotech as a driver of economic growth has helped the industry score big in Congress, where legislators are now advancing the item on the biotech agenda: reform of the Food and Drug Administration. : On Capitol Hill, biotech chief executive officers (CEOs) individually and in two en-masse meetings with lawmakers in the past year, have portrayed FDA as an obstacle to success. The big pharmaceutical companies have made that argument for years and have funnelled contributions to lawmakers to help win their case. But the drug companies have never received a payback in the FDA arena. Biotech has been more subtle and has won friends more easily, without a lot of contributions. Unlike Pharmaceutical Research and Manufacturers of America, the Biotech Industry Organization does not even have a political action committee (PAC). BIO president Carl Feldbaum says that the industry does not need to give . money to get what it wants. "We have a powerful message that gives us the access we need", says Feldbaum. : That message: Biotech is made up of small, entrepreneurial companies that are the future of drug discovery. Besides, biotech does not have a lot to give. The revenues of the US-based biotechnology companies increased in 1995 by 18% to US$8’7 billion, but product approvals are few and far between. According to the 1996 edition of Ernst & Young’s annual industry survey, so far in 1995, only 16
huge
many
highest
cate
first half of 1995. Most of the Binder and Raab contributions went to their local congressmen. Genenzyme, which is based in Cambridge, Massachusetts, has also been active, donating to a public-policy group closely linked to House Speaker Newt Gingrich (Republican, Georgia). Genzyme CEO Henri Termeer has also given to Senator Ted Kennedy (Democrat, Massachusetts) and
ing power. Congressional aides speaking to a BIO meeting on Sept 28 thanked the audience for the industry’s help in creating FDA overhaul plans. An aide to Kassebaum praised biotech for not engaging in rhetor-
comparison with drug company giving. Merck, for instance, has given$255 600 since 1989 to members of Congress, according to the Center for Responsible Politics. Glaxo has given
FDA. She said that the plan would be aimed at protecting patients’ rights, redefine FDA’s mission, require the agency to report each year on how it is meeting new performance standards, and reconfigure the approval process for early clinical trials. Biotech has complained about FDA holdups in the early stages of product development. An aide to Kennedy said that the Senate would also aim to get rid of
period. Despite the drug companies’ . largesse, many in Congress with the power:
process for their products is outmoded. Parroting the biotechnology sector’s
Representative
Joe Kennedy (Democrat, Massachusetts), who represent his area. The money pales in
:
ical attacks Kassebaum
on
burdens". antiquated $515 822 since 1989, and SmithKline "unnecessary, Biotech has said that the FDA approval Beecham has donated$214 200 over the same
overhaul FDA have tended to listen more to biotech companies. The House proposal, introduced by Representative Ron Wyden (Democrat, Oregon), was virtually written by a BIO consultant. : This bill is likely to be passed over in favour of a plan to be introduced by Bliley, but that will probably include some of BIO’s proposals, says Feldbaum. The major Senate proposal, being written by Senators Nancy Kassebaum (Republican, Kansas) and Kennedy, is also heavily influenced by biotech. The bills are not guaranteed passage, and may not to
major
see
message, the Kennedy aide said that biotech is an important industry in Massachusetts, one that the Senators see as an "engine for future growth", and as the "source of future medical breakthroughs". However, the aide noted that, despite biotech’s goodwill, FDA reform is still "a fragile endeavour", that could be derailed by any number of political pressures or disagreements about what really needs to be done to improve the FDA review and
approval process. Alicia Ault Barnett
High-dose retinol associated with birth
defects
Because of the public health importance of the findings, the New England Journal of : Medicine has lifted its embargo for a paper scheduled for its Nov 23 issue. The study has shown that the risk of having a baby with cranial neural crest defects increases steadily with daily intakes of preformed "significant" products were approved, : vitamin A of above 10 000 IU (figure). while 19 products either did not get FDA This threshhold is about four times the approval or had disappointing trial results, : recommended allowance for dietary causing a drop,in stock value or layoffs. : women. The excess risk for women adult taking Even so, some biotechnology firms do . more than 10 000 IU preformed vitamin have most
PACs, notably Amgen and Genentech, and some CEOs individually A from supplements is 1 in 57, compared with the risk for those taking less than donate. According to the Washington DCbased Center for Responsive Politics, 5000 IU a day. The risk was associated Amgen has given in the past few years to mainly with high-supplement intake key senators and congressmen involved in before the 7th week of gestation. Over 22 000 pregnant women were FDA reform, most recently giving US between 1984 and 1987. 121 interviewed to Tom $1000 Representative Bliley of 339 birth defects were of cranial neural whose committee (Republican, Virginia), has jurisdiction over FDA matters. : crest origin (craniofacial, central nervous In 1993-94, Amgen CEO Gordon system, thymus, and heart defects). The Binder and his wife gave$9500 of their trend for risk was less striking for own funds, to both Democrats and musculoskeletal and urogenital tract Republicans. From January to June this defects than for cranial neural crest year, Binder gave$2500,$1000 of which defects and not discernible for neural tube went to the Republic congressional camdefects, which were considered separately. The study examined preformed vitamin paign committee. Former Genentech
Estimated prevalence ratio of birth defects related to the cranial neural crest by amount of retinol intake during first trimester of pregnancy Reproduced with permission from New
England Journal
of Medicine.
carotenoids that have been associated with teratogenic effects. Although betacarotene can be converted in vivo to retinol, existing data suggest that high beta-carotene intake does not raise vitamin A in the body sufficiently to exceed the threshhold for teratogenic effects.
CEO Kirk Raab gave$7000 of his own A, not beta-carotene or other carotenoids. money during 1993-94, and$5500 in the It is the retinoids rather than the Vivien Choo
1027
on
action at all until early next year, but indibiotech’s growing prowess as a lobby-
Capitol Hill
The US biotechnology industry is considered a crown jewel of American innovation, even if the promise has yet to be fully realised. But the potential is so alluring that biotech companies still attract amounts of investment capital and states have bent over backwards extending tax breaks to firms looking for a place to call home. The perception of biotech as a driver of economic growth has helped the industry score big in Congress, where legislators are now advancing the item on the biotech agenda: reform of the Food and Drug Administration. : On Capitol Hill, biotech chief executive officers (CEOs) individually and in two en-masse meetings with lawmakers in the past year, have portrayed FDA as an obstacle to success. The big pharmaceutical companies have made that argument for years and have funnelled contributions to lawmakers to help win their case. But the drug companies have never received a payback in the FDA arena. Biotech has been more subtle and has won friends more easily, without a lot of contributions. Unlike Pharmaceutical Research and Manufacturers of America, the Biotech Industry Organization does not even have a political action committee (PAC). BIO president Carl Feldbaum says that the industry does not need to give . money to get what it wants. "We have a powerful message that gives us the access we need", says Feldbaum. : That message: Biotech is made up of small, entrepreneurial companies that are the future of drug discovery. Besides, biotech does not have a lot to give. The revenues of the US-based biotechnology companies increased in 1995 by 18% to US$8’7 billion, but product approvals are few and far between. According to the 1996 edition of Ernst & Young’s annual industry survey, so far in 1995, only 16
huge
many
highest
cate
first half of 1995. Most of the Binder and Raab contributions went to their local congressmen. Genenzyme, which is based in Cambridge, Massachusetts, has also been active, donating to a public-policy group closely linked to House Speaker Newt Gingrich (Republican, Georgia). Genzyme CEO Henri Termeer has also given to Senator Ted Kennedy (Democrat, Massachusetts) and
ing power. Congressional aides speaking to a BIO meeting on Sept 28 thanked the audience for the industry’s help in creating FDA overhaul plans. An aide to Kassebaum praised biotech for not engaging in rhetor-
comparison with drug company giving. Merck, for instance, has given$255 600 since 1989 to members of Congress, according to the Center for Responsible Politics. Glaxo has given
FDA. She said that the plan would be aimed at protecting patients’ rights, redefine FDA’s mission, require the agency to report each year on how it is meeting new performance standards, and reconfigure the approval process for early clinical trials. Biotech has complained about FDA holdups in the early stages of product development. An aide to Kennedy said that the Senate would also aim to get rid of
period. Despite the drug companies’ . largesse, many in Congress with the power:
process for their products is outmoded. Parroting the biotechnology sector’s
Representative
Joe Kennedy (Democrat, Massachusetts), who represent his area. The money pales in
:
ical attacks Kassebaum
on
burdens". antiquated $515 822 since 1989, and SmithKline "unnecessary, Biotech has said that the FDA approval Beecham has donated$214 200 over the same
overhaul FDA have tended to listen more to biotech companies. The House proposal, introduced by Representative Ron Wyden (Democrat, Oregon), was virtually written by a BIO consultant. : This bill is likely to be passed over in favour of a plan to be introduced by Bliley, but that will probably include some of BIO’s proposals, says Feldbaum. The major Senate proposal, being written by Senators Nancy Kassebaum (Republican, Kansas) and Kennedy, is also heavily influenced by biotech. The bills are not guaranteed passage, and may not to
major
see
message, the Kennedy aide said that biotech is an important industry in Massachusetts, one that the Senators see as an "engine for future growth", and as the "source of future medical breakthroughs". However, the aide noted that, despite biotech’s goodwill, FDA reform is still "a fragile endeavour", that could be derailed by any number of political pressures or disagreements about what really needs to be done to improve the FDA review and
approval process. Alicia Ault Barnett
High-dose retinol associated with birth
defects
Because of the public health importance of the findings, the New England Journal of : Medicine has lifted its embargo for a paper scheduled for its Nov 23 issue. The study has shown that the risk of having a baby with cranial neural crest defects increases steadily with daily intakes of preformed "significant" products were approved, : vitamin A of above 10 000 IU (figure). while 19 products either did not get FDA This threshhold is about four times the approval or had disappointing trial results, : recommended allowance for dietary causing a drop,in stock value or layoffs. : women. The excess risk for women adult taking Even so, some biotechnology firms do . more than 10 000 IU preformed vitamin have most
PACs, notably Amgen and Genentech, and some CEOs individually A from supplements is 1 in 57, compared with the risk for those taking less than donate. According to the Washington DCbased Center for Responsive Politics, 5000 IU a day. The risk was associated Amgen has given in the past few years to mainly with high-supplement intake key senators and congressmen involved in before the 7th week of gestation. Over 22 000 pregnant women were FDA reform, most recently giving US between 1984 and 1987. 121 interviewed to Tom $1000 Representative Bliley of 339 birth defects were of cranial neural whose committee (Republican, Virginia), has jurisdiction over FDA matters. : crest origin (craniofacial, central nervous In 1993-94, Amgen CEO Gordon system, thymus, and heart defects). The Binder and his wife gave$9500 of their trend for risk was less striking for own funds, to both Democrats and musculoskeletal and urogenital tract Republicans. From January to June this defects than for cranial neural crest year, Binder gave$2500,$1000 of which defects and not discernible for neural tube went to the Republic congressional camdefects, which were considered separately. The study examined preformed vitamin paign committee. Former Genentech
Estimated prevalence ratio of birth defects related to the cranial neural crest by amount of retinol intake during first trimester of pregnancy Reproduced with permission from New
England Journal
of Medicine.
carotenoids that have been associated with teratogenic effects. Although betacarotene can be converted in vivo to retinol, existing data suggest that high beta-carotene intake does not raise vitamin A in the body sufficiently to exceed the threshhold for teratogenic effects.
CEO Kirk Raab gave$7000 of his own A, not beta-carotene or other carotenoids. money during 1993-94, and$5500 in the It is the retinoids rather than the Vivien Choo
1027