Bayer HealthCare Pharmaceuticals
|Headquarters||Montville, New Jersey, U.S.|
|Key people||Reinhard Franzen President & CEO|
|Products||Leukine, Campath, Fludara, Climara, Levlen, Betaseron, and Betapace|
|Revenue||$US 1.3 billion (2004)|
Bayer HealthCare Pharmaceuticals is a research-based pharmaceutical company headquartered in Montville, New Jersey, in the United States, with operations in Wayne, New Jersey; Bothell, Washington; Seattle, Washington; and Richmond, California. It is a subsidiary of Bayer, headquartered in Leverkusen, Germany. In 2004 Bayer HealthCare Pharmaceuticals recorded US sales of $ 1.3 billion. Bayer HealthCare Pharmaceuticals employs approximately 2,400 people in the United States. Before 2008 Bayer HealthCare Pharmaceuticals was known as Berlex.
As of 2006, the Bayer HealthCare Pharmaceuticals portfolio consists of 19 Food and Drug Administration (FDA)-approved drugs within the business areas of female healthcare, diagnostic imaging, oncology, and therapies related to the treatment of cardiovascular and neurological conditions. These products are:
- Angeliq (drospirenone and estradiol)
- Betapace (sotalol HCI)
- Betapace AF (sotalol HCI)
- Betaseron (interferon beta-1b)
- Campath (alemtuzumab)
- Climara (estradiol transdermal system)
- Climara pro (estradiol/levonorgestrel transdermal system)
- Feridex I.V. (ferumoxides injectable solution) (also known as Endorem® and ferumoxides), discontinued by AMAG Pharma in November 2008
- Fludara (fludarabine phospate)
- Leukine (sargramostim)
- Levlen 28 (levonorgestrel and ethinyl estradiol tablets)
- Levlite (levonorgestrel and ethinyl estradiol tablets)
- Magnevist (gadopentetate dimeglumine)
- Menostar (estradiol transdermal system)
- Mirena (levonorgestrel-releasing intrauterine system)
- Refludan (lepirudin)
- Tri-Levlen 28 (levonorgestrel and ethinyl estradiol tablets)
- Ultravist (iopromide)
- Yasmin (drospirenone and ethinyl estradiol tablets)
Research and development
According to its website, Bayer HealthCare Pharmaceuticals' current research and development is focused in the same areas as its extant, FDA-approved products: diagnostic imaging, therapeutics, gender-specific healthcare, and oncology. Bayer HealthCare Pharmaceuticals claims to have in its product pipeline at least 8 oncology drugs in various stages of development.
Bayer Healthcare’s Women’s Health Division is home to a number of well respected contraceptives including Yaz, Yasmine, and Yasminelle, and Mirena. To supplement and further aid women in their contraceptive needs, Bayer is offering three new contraceptives: Beyaz, Natazia, and Safryl. In addition to offering contraception benefits, these brands offer the added benefit of folate which is essential in preventing neural tube defects in infants when patients do choose to start their family. Bayer’s pipeline includes many innovative technologies that will supplement the already strong portfolio in the upcoming years in a variety of therapeutic areas that pertain to the improvement of a woman’s wellbeing.
- Leukine. Berlex paid for a study that ran in the May 26, 2005, issue of the New England Journal of Medicine, which concluded that its leukemia drug Leukine “decreased disease severity and improved the quality of life in patients with active Crohn’s disease.” The lead author, Joshua Korzenik of Harvard Medical School and Massachusetts General Hospital, was a paid consultant for Berlex, and he co-invented the patent behind the drug. Korzenik created a "firewall" to protect the integrity of the study, consisting of two committees to review the study results and process as well and sending trial data to outside clinicians for review.
- Diane-35. The Working Group of a Canadian women's health organization wrote to the Medical Advisory Board of Health Canada to complain about the ad campaign for Diane-35, which violates Canada's laws about direct-to-consumer advertising. The focus of the formal complaint is not just the illegality of prescription drug advertising in Canada, but the poor safety record of this drug and the misleading way in which it is being targeted at young women. The Working Group has called on Health Canada to force Berlex to stop the campaign, to apply strict fines and require that they issue corrective advertising to address the misinformation that has been perpetuated with this campaign.
- Yasmin. Berlex was cited in 2002 and 2003 by the FDA for false and misleading prescription drug advertising.
- Yasmin redux. Bayer HealthCare Pharmaceuticals received an FDA Warning Letter in 2008 for repeated false and misleading YAZ prescription drug advertising. "The TV Ads are misleading because they broaden the drug's indication, overstate the efficacy, and minimize serious risks associated with the use of the drug." One cited advertisement has the narrator stating, "We all know that birth control pills are 99% effective and can give you shorter, lighter periods. But did you know there's a Pill that could do more?" The advertisement then displays images of energetic, euphoric, playful women singing "We're Not Gonna Take It" as they kick, punch, and push words describing symptoms "IRRITABILITY," "MOODINESS," "BLOATING," and "FEELING ANXIOUS," away from the screen, followed by the claim "It's YAZ! And there's no other birth control like it." According to the FDA," These violations are concerning from a public health perspective because they encourage use of YAZ in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with YAZ. One indication in the warning letter, acne, has received approval in the US.
- Climara. Berlex was cited in 2003 by the FDA for false and misleading prescription drug advertising. 
- "Feridex - Products - AMAG Pharmaceuticals". Amagpharma.com. Retrieved 2012-06-20.
- Bernstein DS (2006-04-12). "Med school drug pushers: How scientists are selling out to drug companies". The Boston Phoenix. Retrieved 2008-10-12.
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- Text of FDA letter to Berlex, ordering them to cease misleading advertising of Yasmin.
- "Med school drug pushers: How scientists are selling out to drug companies," by David S. Bernstein, The Phoenix
- Text of FDA letter to Bayer HealthCare Pharmaceuticals, Inc., to immediately cease dissemination of violative promotional materials for YAZ.
- Screen capture images from misleading advertisements.
- Text of FDA letter to Berlex, ordering them to cease false and misleading advertising of Climara.