Introduction

Bayer HealthCare Pharmaceuticals is a research-based pharmaceutical company

Pharmaceutical company

The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...

 headquartered in Montville, New Jersey with operations in Wayne, New Jersey

Wayne, New Jersey

Wayne is a Township in Passaic County, New Jersey, United States, located less than from midtown Manhattan. As of the United States 2000 Census, the township had a total population of 54,069....

; Bothell, Washington

Bothell, Washington

Bothell is a city located in King and Snohomish Counties in the state of Washington. It is part of the Seattle metropolitan area. The population was 33,505 as of the 2010 census...

; Seattle, Washington; and Richmond, California

Richmond, California

Richmond is a city in western Contra Costa County, California, United States. The city was incorporated on August 7, 1905. It is located in the East Bay, part of the San Francisco Bay Area. It is a residential inner suburb of San Francisco, as well as the site of heavy industry, which has been...

. It is a subsidiary of Bayer

Bayer

Bayer AG is a chemical and pharmaceutical company founded in Barmen , Germany in 1863. It is headquartered in Leverkusen, North Rhine-Westphalia, Germany and well known for its original brand of aspirin.-History:...

, headquartered in Leverkusen

Leverkusen

Leverkusen is a city in North Rhine-Westphalia, Germany on the eastern bank of the Rhine. To the South, Leverkusen borders the city of Cologne and to the North is the state capital Düsseldorf....

, Germany

Germany

Germany , officially the Federal Republic of Germany , is a federal parliamentary republic in Europe. The country consists of 16 states while the capital and largest city is Berlin. Germany covers an area of 357,021 km2 and has a largely temperate seasonal climate...

. 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.

Products

As of 2006, the Bayer HealthCare Pharmaceuticals portfolio consists of 19 Food and Drug Administration

Food and Drug Administration

The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 (FDA)-approved drugs within the business areas of female healthcare, diagnostic imaging, oncology

Oncology

Oncology is a branch of medicine that deals with cancer...

, and therapies related to the treatment of cardiovascular and neurological conditions. These products are:

• Angeliq (drospirenone and estradiol)
• Betapace AF (sotalol HCI)
• Betapace (sotalol HCI)
• Betaseron (interferon beta-1b)
• Campath (alemtuzumab)
• Climara Pro (estradiol/levonorgestrel transdermal system)
• Climara (estradiol transdermal system)
• Feridex I.V. (ferumoxides injectable solution)
• 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
  IntraUterine System
  The IUD with progestogen, intrauterine system , or IntraUterine Contraceptive is a long-acting reversible hormonal contraceptive device that is placed in the uterus. An IUS has a hormone cylinder that releases a progestin called levonorgestrel...
  
  )
• Refludan (lepirudin)
• Tri-Levlen 28 (levonorgestrel and ethinyl estradiol tablets)
• Ultravist (iopromide)
• Yasmin
  Yasmin
  -Etymology:Yasmin is the name in Persian for a flowering plant, and from which the name Jasmine derives.The pronunciation of Yasmin is often parallel with the English Jasmine, but in Arabic, Persian and Turkish, the "s" is not taken as a "z", and so is often pronounced as .-Yasemin:* Yasemin...
  
   (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.

Controversy

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.[^ a b "Med school drug pushers: How scientists are selling out to drug companies", by David S. Bernstein, The Phoenix. Published April 12, 2006. Accessed 8 Feb 2007)

2. 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

Direct-to-consumer advertising

Direct-to-consumer advertising usually refers to the marketing of pharmaceutical products but can apply in other areas as well. This form of advertising is directed toward patients, rather than healthcare professionals. The Food and Drug Administration holds responsibility of regulating DTC...

. 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.

3. Yasmin. Berlex was cited in 2002 and 2003 by the FDA for false and misleading prescription drug advertising. http://72.14.209.104/search?q=cache:x26blPuORYEJ:www.fda.gov/cder/warn/2003/11730.pdf+berlex+%2B+false+and+misleading+advertising&hl=en&gl=us&ct=clnk&cd=2 http://www.fda.gov/CDER/warn/2003/11730.pdf

4. Yasmin redux. Bayer HealthCare Pharmaceuticals received an FDA Warning Letter

FDA Warning Letter

The United States Food and Drug Adminstration defines a Warning Letter as "...a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations...

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."http://www.fda.gov/CDER/warn/2008/YAZ_wl.pdfhttp://www.fda.gov/Cder/warn/2008/YAZ_promol.pdf One indication in the warning letter, acne, has received approval in the US.

5. Climara. Berlex was cited in 2003 by the FDA for false and misleading prescription drug advertising. http://www.fda.gov/Cder/warn/2003/11026.pdf