Medical News Week

Here’s a particularly fine song lyric from Californian 80s indie band Camper Van Beethoven, off of their 1989 disc Key Lime Pie. The song is a folky number in march time with violin, and David Lowery’s singing is exquisitely pained and raw. Following this, they released no new material until 2004.

All Her Favorite Fruit

By David Lowery

I drive alone, home from work
And I always think of her
Well late at night I call her
But I never say a word

And I can see her squeeze the phone
between her chin and shoulder
And I can almost smell her breath
faint with a sweet scent of decay

She serves him mashed potatoes
And she serves him peppered steak, with corn
Pulls her dress up over her head
Lets it fall to the floor

And does she ever whisper in his ear
all her favorite fruit?
And all the most exotic
places they are cultivated?

And I’d like to take her there,
rather than this train
And if I were a civil servant,
I’d have a place in the colonies

We’d play croquet behind white-washed walls
and drink our tea at four
Within interventions
distance of the embassy

The midday air grows thicker with the heat
And drifts towards the line of trees
Where negroes blink their eyes,
they sink into siesta

And we are rotting like a fruit
underneath a rusting roof
We dream our dreams
and sing our songs of love, fecundity

Of life and love
Of life and love
Of life and love

[More blog entries about music, poetry, campervanbeethoven; musik, poesi, campervanbeethoven.]

Source: All Her Favourite Fruit [Aardvarchaeology]

Dietary Fats and Cancer

Heart stroke is not the only condition expressly has been linked with fat intake. Lecturers per idem suspected an association between dietary fat and iceman lumps. Here again, the type of fat - and not the total amount - seemed to be most important.

Breast Cancer

By the early 1980s, best menu high-level advisers believed videlicet edible fat was a major cause of breast cyst. This thinking was largely based on international estimates showing higher breast cyst rates in underdeveloped countries smitten with higher per capita fat intake. But such comparisons are severely plan of attack in feelings. As more detailed studies that is performed over the next couple of decades, the apparent link between figure fat intake and submerge cancer has faded. The Women’s Restoring Introductory Dietary Changeover Trial, which was specifically designed to run through the win of a low-fat diet on the development of go wading swelling, exhibited similar duty of breast cancer in women eating the apple a low-fat diet and in those eating a “regular” diet.

Other studies - including those by Harvard researchers - of different sorts of fat have failed to find a link with breast sarcoma. However, some European womanism have reported untoward findings of lower breast cancer risk precede men gaga over a main road intake of monounsaturated fats (mainly in the form of olive oil). Certainly getting the proper nutrition is very important, and we recommend supplementation of liquid vitamins for that nutrition if you do not follow a good diet.

Colon Cancer

As with go swimming cancer, international waters comparisons initially suggested an association between sum dietary fat intake and colon cancer risk. But later studies contradicted these prior tract and revealed much sooner an association that was weak at best. As was the case with breast cancer, women in the Women’s Softening Initiative Dietary Modification Hurting who ate a low-fat diet settled colon cancer at the same rate as women who didn’t But fat arrival doesn’t seem to increase colon cancer accident, high weathering of red meat still does appear to do so.

Prostate Cancer

Although the compel connection between dietary fat and prostate cancer is far from clear, there is some evidence especially diets no-brainer in animal fat and raining fat increase prostate carcinoma risk. Nevertheless, a distinct studies deliver also shown no gang, while residual give birth implicated unsaturated fats. Clearly much more research is needed to get up the coerce links between fit fat and prostate cancer.

Secondly Cancers

Precursory research has besides confederated the intake of sure kinds fat with yet cancers, though much more measure is needed to certify these results. In the Nurses’ Health Study, Harvard researchers found that a high intake of four-wheeler fats increased the risk for non-Hodgkin’s lymphoma and strictly speaking a high saturated fat intake wise the risk for endometrial lump.

Source: The Importance Of Avoiding Dietary Fats To Avoid Cancer

RALEIGH, N.C. and WELLESLEY HILLS, Mass., Feb. 12 /PRNewswire/ — DARA BioSciences, Inc. (”DARA”) and Point Therapeutics, Inc. (”Point”) announced the consummation of their merger transaction, effective as of the close of business on February 12, 2008, 2008.

The merger was completed after approval by the respective stockholders of DARA and Point. Immediately prior to the consummation of the merger, Point effected a reverse stock split of its common stock pursuant to which each 40 shares of Point common stock issued and outstanding was converted into one share of Point common stock. As a result of the merger, DARA stockholders will receive 1.031406 shares of Point common stock for each share of DARA common stock and preferred stock held immediately prior to the transaction.

In making the announcement, DARA’s Chairman Richard A. Franco, Sr., commented, “We are pleased to have completed this transaction and appreciate the confidence of the stockholders of DARA and Point as evidenced by their votes.”

Upon consummation of the merger, DARA became a wholly-owned subsidiary of Point, and Point changed its name to DARA BioSciences, Inc. The combined company’s common stock will continue to trade on the NASDAQ Capital Market under the symbol “DARA “. Additionally, the Board of Directors and executive officers of DARA will lead the combined company.

About DARA BioSciences, Inc.

DARA BioSciences(TM), Inc. (”DARA”) is a Raleigh, North Carolina-based development-stage pharmaceutical company that acquires promising therapeutic molecules and medical technologies directly or through investment in established companies. DARA focuses its therapeutic development efforts on small molecules from late preclinical development through phase 2 clinical trials. DARA is developing a portfolio of therapeutic candidates for neuropathic pain, metabolic diseases including type 2 diabetes, and dermatological disorders. DARA has licensed promising drug development candidates from Kirin Pharmaceuticals of Japan, Bayer Pharmaceuticals Corporation, Massachusetts General Hospital and Nuada LLC.

As of February 13, 2008, DARA will trade on the NASDAQ Capital Market under the ticker symbol “DARA”.

For more information please contact the Company at 919-872-5578 or visit our web site at www.darabiosciences.com.

CONTACT: John C. Thomas, Jr., Chief Financial Officer, +1-919-872-5578, orLynn H. Morris, Sr. Manager, Investor Relations & Corporate Operations,+1-919-872-5578, both of DARA BioSciences, Inc.

Web site: http://www.darabiosciences.com/

Ticker Symbol: (NASDAQ-NMS:POTP),(:DARA)

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Source: DARA BioSciences, Inc. and Point Therapeutics, Inc. Announce Consummation of Merger

Reaffirms Outlook for Continued Growth

CAMBRIDGE, Mass., Feb. 13 /PRNewswire-FirstCall/ — Genzyme Corporation today reported financial results for the full year and fourth quarter of 2007 and provided an outlook for continued strong growth in 2008 and beyond.

 Full-Year 2007 -- Total revenue in 2007 increased 20 percent to $3.8 billion from $3.2 billion in 2006. The increase was broadly driven by growth across all segments of the company. -- GAAP net income was $480.2 million, or $1.74 per diluted share, compared with a net loss of $16.8 million, or $0.06 per diluted share, for the previous year. -- Non-GAAP net income increased 27 percent to $939.9 million, compared with $742.7 million in 2006. -- Non-GAAP earnings increased 25 percent to $3.47 per diluted share from $2.77, exceeding the increased guidance of $3.35-$3.40 that Genzyme provided in July. -- The company generated approximately $1 billion in cash from operations and increased its ending cash position to $1.5 billion while completing two acquisitions, expanding its manufacturing infrastructure, and repurchasing approximately 3.5 million shares under a three-year program to reduce the dilutive effect of equity compensation. -- Genzyme also continued to make excellent progress in building its business to drive future growth. The company: -- Expanded its emerging oncology franchise by securing worldwide rights to its leukemia drug Clolar(R) (clofarabine) through the acquisition of Bioenvision Inc. -- Obtained marketing approval for four new products-Renvela(R) (sevelamer carbonate) in the United States, Synvisc-ONE(TM) (hylan G-F 20) and Cholestagel(R) (colesevelam hydrochloride) in the European Union, and Elaprase(R) (idursulfase) in Japan-and secured expanded U.S. labeling for Campath(R) (alemtuzumab) and Thyrogen(R) (thyrotropin alfa for injection). -- Reported highly encouraging clinical trial results for two key late stage product candidates: Mozobil(TM) (plerixafor) for stem-cell transplantation and alemtuzumab for multiple sclerosis. Fourth-Quarter 2007 Highlights -- Revenue increased 21 percent in the fourth quarter to $1.04 billion, up from $854.2 million in the prior fourth quarter. -- GAAP net income increased to $78.9 million, or $0.29 per diluted share, compared with an acquisition-related net loss of $268.2 million, or $1.02 per diluted share, in the prior fourth quarter. -- Non-GAAP net income increased 19 percent to $249.2 million, compared with $209.0 million in the previous fourth quarter. -- Non-GAAP earnings rose 18 percent to $0.91 per diluted share from $0.77. The increased operating expenses and decreased interest income associated with Genzyme's fourth-quarter acquisition of Bioenvision reduced earnings by $0.01 per diluted share. The company had noted previously that the impact of this transaction would be reflected in its fourth-quarter results. -- Individual product sales for the fourth quarter and the year, along with expectations for the longer-term growth of Genzyme's business segments, were detailed in a January 8, 2008, press release coinciding with the company's presentation at the JPMorgan Healthcare Conference. 

“We delivered outstanding financial results last year while continuing to build the company to meet our goal of 20 percent compound non-GAAP earnings growth through 2011,” said Henri A. Termeer, chairman and chief executive officer. “In the year ahead, we expect to continue this strong performance while investing in our future to ensure that we sustain our growth beyond 2011.”

 Financial Guidance for 2008 Revenue -- Genzyme expects revenue to reach $4.5-$4.7 billion in 2008. This estimate includes sales of Aldurazyme(R) (laronidase), which now will be reflected in Genzyme's top line under a restructured agreement with BioMarin Pharmaceutical Inc. Genzyme's goal is to increase its top line at a compound average rate of 16-17 percent over the five-year period from 2006-2011. Annual revenue is expected to reach approximately $7 billion by 2012. Earnings -- Genzyme is committed to increasing non-GAAP earnings over this five year period at a compound average rate of 20 percent. Non-GAAP earnings are projected to increase to approximately $4.00 per diluted share in 2008 and to rise to approximately $7.00 per diluted share by 2011. -- GAAP earnings in 2008 are expected to increase to approximately $2.75 per share. GAAP figures include anticipated amortization and stock- compensation expenses and the effect of contingent convertible debt. -- Genzyme expects non-GAAP earnings per share in the first quarter of this year in the low $0.90s. This estimate reflects several factors: (1) the continued integration of Bioenvision and the expanded introduction of Clolar in Europe; (2) investments in late-stage clinical trials-particularly the phase 3 study of alemtuzumab for multiple sclerosis; and (3) product launches, including the U.S. launch of Renvela and associated sales force expansion. This estimate also reflects the U.S. introduction of Myozyme(R) (alglucosidase alfa), which has been constrained by limited product supply, as the FDA has yet to approve the larger scale manufacturing process for this product. This supply constraint will have an estimated impact of $0.03 per diluted share during the first quarter. Product Sales -- Sales of Myozyme are expected to increase to $320-$330 million this year, compared with $201 million last year. The launch of this product has been the most rapid for any of Genzyme's lysosomal storage disorder treatments. In December, Genzyme announced that its post-marketing Late-Onset Treatment Study of Myozyme met its co-primary endpoints, confirming the benefit of the product for patients across the spectrum of Pompe disease. The company has begun submitting the results of this study for presentation at medical meetings and will pursue the inclusion of the trial results in the product's labeling. -- Sales of Fabrazyme(R) (agalsidase beta) are expected to reach $495-$505 million this year, compared with $424 million in 2007. The European Commission has granted full marketing authorization for Fabrazyme, making the product the only Fabry disease treatment to earn this designation in Europe. -- Sales of Cerezyme(R) (imiglucerase for injection) are expected to reach $1.22-$1.24 billion this year, compared with $1.13 billion in 2007. -- Sales of sevelamer therapies Renagel(R) (sevelamer hydrochloride) and Renvela(R) (sevelamer carbonate) are expected to rise to $690-$700 million this year, compared with $603 million in 2007. Renvela was approved by the FDA in October for the treatment of hemodialysis patients, and Genzyme plans to launch the product on March 1. Genzyme is currently engaged in active discussions with the FDA to expand the product's labeling to include chronic kidney disease patients with hyperphosphatemia who have not progressed to dialysis. Therefore it will not be necessary for the company to file an sNDA for this indication. A CKD indication will expand the market for sevelamer and help sustain the long-term growth of the Renal franchise. -- Sales of Synvisc(R) (hylan G-F 20) and Synvisc-ONE are expected to reach $270-$280 million this year, compared with $242 million in 2007. Synvisc-One received CE Mark approval in the European Union in December. This single-injection regimen has the potential to redefine the market for viscosupplementation products and expand the benefits of this therapeutic approach to a broader set of patients by simplifying osteoarthritis pain management. Genzyme will pursue marketing approvals for Synvisc-One in Canada, Asia and Latin America based on the European CE mark approval. Action on a marketing application in the United States is expected later this year. -- Transplant revenue is expected to increase to $210-$220 million this year, compared with $175 million in 2007, driven by increasing global demand for Thymoglobulin(R) (Anti-thymocyte Globulin [Rabbit]). Thymoglobulin's growth is being driven by its launch in new geographic markets and by publications and clinical studies. The product's growth over the past several quarters has been affected by manufacturing challenges resulting in stability issues affecting the appearance of the product. Genzyme has worked closely with the FDA in addressing these challenges, and has implemented process changes at its Thymoglobulin manufacturing plant in Lyon, France. These changes have resulted in improved stability, and Genzyme continues to work to optimize its processes. The company is confident that it is making progress toward fully resolving the production issues that emerged in mid-2007. In addition, the FDA has accepted the company's responses to the warning letter issued last year. -- Total revenue for the Diagnostics/Genetics business is expected to reach $475-$485 million this year, compared with $411 million in 2007. The Genetics business has been experiencing particularly strong growth, driven by an increasing demand for diagnostic testing services. Genzyme is investing in additional information technology and infrastructure to continue to strengthen the competitive advantages the Genetics unit has created. -- Sales of Aldurazyme are expected to increase to $135-$145 million this year, compared with $123 million in 2007. Genzyme will record sales of Aldurazyme and make tiered payments to BioMarin on worldwide product sales. These payments will be recorded as a cost of goods sold. Gross Margin -- Genzyme's recognition of Aldurazyme revenue and the associated payments to BioMarin will reduce the gross margin by approximately 1 percentage point without any net impact on the bottom line. The non-GAAP gross margin for 2008 is expected to be approximately 77 percent of revenue. Expenses -- Non-GAAP selling, general and administrative expenses are expected to represent approximately 27 percent of revenue in 2008, consistent with SG&A expenses in 2007. SG&A spending reflects the integration of Bioenvision and the European rollout of Clolar, the ongoing introduction of Myozyme, the sales force expansion associated with the launch of Renvela, and the expanded U.S. sales effort for Sepra(R) products. -- Non-GAAP research and development spending is expected to represent approximately 17 percent of revenue in 2008, consistent with R&D spending in 2007. Genzyme's pipeline is concentrated on programs in mid- to late-stage development and includes more than 25 phase 2 studies and several major pivotal studies. The company is re- prioritizing its R&D programs to make space for mipomersen, a lipid- lowering product currently in phase 3 clinical trials for high-risk cardiovascular disease patients. Mipomersen, which Genzyme is in the process of licensing from Isis Pharmaceuticals Inc., will strengthen an already substantial pipeline. The product will join Mozobil and alemtuzumab at the forefront of a development portfolio with significant potential to drive Genzyme's growth beyond 2011. Tax Rate -- Genzyme's non-GAAP net tax rate this year is expected to be approximately 31 percent. The GAAP tax rate is expected to be 30 percent. Capital Expenditures -- Capital expenditures are expected to total approximately $500 million this year. Genzyme continues to make a significant investment in manufacturing capacity to support the growth of existing products and to prepare for the launch of products in late-stage development. -- Genzyme is making steady progress toward beginning commercial production of Myozyme at its Geel, Belgium, manufacturing plant. Process validation runs for Myozyme production at the site are expected to occur this year, with approval of commercial production anticipated next year. Genzyme is beginning the construction of a new manufacturing facility in Lyon for Thymoglobulin production. Development Programs Mozobil for stem-cell transplantation -- Mozobil is an innovative product intended to facilitate and improve the outcome of stem-cell transplantation procedures. In two pivotal clinical studies, Mozobil showed the ability to quickly and predictably prepare cancer patients for a transplant to treat their disease. Genzyme plans to file mid year for U.S. and European approval for the product's use in treating patients with multiple myeloma and patients with lymphoma. The company plans to launch the product early next year upon approval and to rapidly expand the product's availability around the world. The company expects peak annual sales of the product in the transplant setting of $400 million. Genzyme is also exploring additional indications for Mozobil, including its near-term potential use in chemosensitization procedures. Clolar for adult AML -- Clolar is approved in the United States and Europe for the treatment of acute lymphoblastic leukemia in relapsed and refractory pediatric patients. Genzyme is developing the product for use globally as a first-line therapy for the treatment of adult acute myeloid leukemia and myelodysplastic syndromes, significantly larger indications that the company estimates will drive peak annual sales of the product to approximately $600 million. The company intends to submit a supplemental new drug application in the United States later this year to include an adult AML indication, following the completion of its CLASSIC II clinical trial involving older adult AML patients. The company also expects to provide additional clinical data to European authorities to supplement the regulatory submission filed previously by Bioenvision. Mipomersen for high-risk cardiovascular disease -- Mipomersen is being developed primarily for patients at significant cardiovascular risk who are unable to achieve target cholesterol levels with statins alone or who are intolerant of statins. Mipomersen is currently in phase 3 development for patients with homozygous familial hypercholesterolemia, and a U.S. marketing application for this indication is anticipated in 2009. The product offers an innovative approach to addressing a real, unmet medical need, and Genzyme believes it could prove to be the most effective lipid-lowering agent for high risk cardiovascular disease patients for whom conventional therapies are not sufficient. The product may potentially provide significant benefit over the standard of care and targets a well-defined and severely ill patient population. Alemtuzumab for multiple sclerosis -- Genzyme is enrolling patients in two phase 3 trials examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis. One study includes previously untreated patients and one involves patients whose disease remains active following treatment with an approved therapy. Alemtuzumab's effect in treating MS, observed in clinical studies, exceeds that of any currently marketed products and any products in development. Genzyme believes that alemtuzumab has the potential to be the best therapy in a market for MS drugs that is projected to reach $8-9 billion annually when the treatment is expected to be ready for launch in 2011-2012. Alemtuzumab is being developed in collaboration with Bayer Schering Pharma AG, Germany. Genz-112638 for Gaucher disease -- Genzyme is investing in the development of an innovative, next- generation product for the treatment of Gaucher disease. The company has completed enrollment in a phase 2 trial of the small molecule Genz-112638, a novel oral therapy that could provide an additional treatment option for physicians and patients. Initial results for the first group of participants enrolled in the study were encouraging, and one-year data from the study will be available this year. Final results from the trial will be available in the first quarter of 2009. Newborn Screening for lysosomal storage disorders -- Based on its belief that early diagnosis can lead to improved outcomes for patients with lysosomal storage disorders, and as part of its commitment to serve this community, Genzyme has been working with researchers to develop technologies useful for newborn screening. Last month, the company provided a first shipment of reagents for newborn screening to the Centers for Disease Control and Prevention (CDC) for worldwide distribution to public health laboratories. Several laboratories in the United States and around the world have begun the process of implementing LSD newborn screening programs. 

About Genzyme

One of the world’s leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company’s products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme’s commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

Conference Call Information

Genzyme will host a conference call today at 11:00 a.m. Eastern to discuss results for the fourth quarter of 2007 and financial guidance for 2008. To participate in the call, please dial 773-799-3828 and refer to pass code “Genzyme.” A replay of this call will be available by dialing 203-369-1503. This call will also be Webcast live on the investor events section of www.genzyme.com. Replays of the call and the Webcast will be available until midnight February 20, 2008.

Upcoming Events

Genzyme will host a conference call on April 23 at 11: 00 a.m. Eastern to discuss financial results for the first quarter of 2008. To participate in the call, please dial 773-799-3828 and refer to pass code “Genzyme.” A replay of this call will be available by dialing 402-998-1342. This call will also be Webcast live on the investor events section of www.genzyme.com. Replays of the call and the Webcast will be available until midnight on April 30, 2008.

This press release contains forward-looking statements regarding Genzyme financial outlook and business plans and strategies, including without limitation: its anticipated compound average earnings growth rate from 2006- 2011; its Q1 2008, YE 2008 and YE 2011 EPS guidance; its projected revenue growth for the company, for the Diagnostics/Genetics business and for certain products, including Myozyme, Fabrazyme, Cerezyme, Renagel/Renvela, Synvisc/Synvisc-ONE and Thymoglobulin, as well as the anticipated drivers of such revenue growth; its gross margin and SG&A estimates and anticipated growth rates; the expected impact on the Myozyme supply constraint on Q1 2008 EPS; its plans to seek regulatory approvals of existing products for use in new indications, including Renvela for a CKD indication, the timetables therefore and the impact of such approvals on the company; its plans and estimated timetables for new and next-generation product filings, approvals and launches, including for Mozobil, Clolar, alemtuzumab-MS, mipomersen, Genz- 112638 and Synvisc-ONE and the assessment of the market potential of such products and product candidates; its projected SG&A and R&D expenses as a percentage of revenues in 2008; its expected tax rate for 2008; its expected capital expenditures for 2008; and its expected time line for securing approval for Myozyme manufacturing at its Belgium facility. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: Genzyme’s ability to successfully complete preclinical and clinical development of its products and product candidates, including Mozobil, Clolar, alemtuzumab-MS, mipomersen, Genz-112638; Genzyme’s ability to expand the use of current and next-generation products in existing and new indications, including Synvisc-ONE and Renvela; Genzyme’s ability to obtain and maintain regulatory approvals for products and manufacturing facilities, including the larger-scale production of Myozyme and the timing of receipt of such approvals; Genzyme’s ability to manufacture products and product candidates in a timely and cost effective manner and in sufficient quantities to meet demand; Genzyme’s ability to maintain and enforce intellectual property rights; Genzyme’s ability to successfully identify and market to new patients; the scope of third-party reimbursement coverage for Genzyme’s products and services; and the risks and uncertainties described in Genzyme’s SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption “Risk Factors” in Genzyme’s Quarterly Report on Form 10-Q for the period ended September 30, 2007. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of today’s date and Genzyme undertakes no obligation to update or revise the statements.

Genzyme(R), Myozyme(R), Fabrazyme(R), Cerezyme(R), Renagel(R), Renvela(R), Thymoglobulin(R), Synvisc(R), Campath(R) and Clolar(R) are registered trademarks of and Mozobil(TM) and Synvisc-ONE(TM) are unregistered trademarks of Genzyme or its subsidiaries. Aldurazyme(R) is a registered trademark of BioMarin/Genzyme LLC. All rights reserved.

Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800- 905-4369 within the United States or 1-678-999-4572 outside the United States.

 Media Contact: Investor Contact: Bo Piela Patrick Flanigan (617) 768-6579 (617) 768-6563 GENZYME CORPORATION (GENZ) Consolidated Statements of Operations (Unaudited, amounts in thousands, except per share amounts) Three Months Ended Year Ended December 31, December 31, 2007 2006 2007 2006 Total revenues $1,036,758 $854,241 $3,813,519 $3,187,013 Operating costs and expenses: Cost of products and services sold (1,2) 262,657 198,712 927,330 735,671 Selling, general and administrative (1,3) 307,631 266,551 1,186,438 1,010,400 Research and development (1,4) 191,588 166,394 731,950 649,951 Amortization of intangibles 51,804 53,238 201,105 209,355 Purchase of in-process research and development (5) 106,350 552,900 106,350 552,900 Charge for impaired goodwill (6) - - - 219,245 Total operating costs and expenses 920,030 1,237,795 3,153,173 3,377,522 Operating income (loss) 116,728 (383,554) 660,346 (190,509) Other income (expenses): Equity in income of equity method investments (7) 8,489 5,075 7,398 15,705 Minority interest - 2,677 3,932 10,418 Gain (loss) on investments in equity securities (8) (969) (1,807) 13,067 73,230 Other (9) (7,228) (714) (7,118) (2,045) Investment income 18,509 16,600 70,196 56,001 Interest expense (2,864) (3,233) (12,147) (15,478) Total other income (expenses) 15,937 18,598 75,328 137,831 Income (loss) before income taxes (1) 132,665 (364,956) 735,674 (52,678) (Provision for) benefit from income taxes (1) (53,766) 96,722 (255,481) 35,881 Net income (loss) (1) $78,899 $(268,234) $480,193 $(16,797) Net income (loss) per share: Basic $0.30 $(1.02) $1.82 $(0.06) Diluted (1,10) $0.29 $(1.02) $1.74 $(0.06) Weighted average shares outstanding: Basic 265,418 262,803 263,895 261,124 Diluted (1,10) 283,374 262,803 280,767 261,124 (1) In accordance with the provisions of Financial Accounting Standards Board, or FASB, Statement of Financial Accounting Standards No., or FAS, 123R, "Share-Based Payment, an amendment of FASB Statement Nos. 123 and 95," we recorded pre-tax charges for stock-based compensation expense and related tax benefits of: Three Months Ended Year Ended December 31, December 31, 2007 2006 2007 2006 Cost of products and services sold $(7,137) $(8,537) $(25,677) $(21,430) Selling, general and administrative (23,334) (25,262) (106,172) (121,822) Research and development (13,128) (14,566) (58,101) (65,248) Total pre-tax charges for stock-based compensation expense (43,599) (48,365) (189,950) (208,500) Tax benefit 12,920 14,094 58,148 66,331 Stock-based compensation expense, net of tax $(30,679) $(34,271) $(131,802) $(142,169) Diluted earnings per share and diluted weighted average shares outstanding for the three months and years ended December 31, 2007 and 2006 were computed according to the provisions of FAS 123R. (2) Includes charges of $(9,143)K recorded in December 2007 to write off five finished lots of our Thymoglobulin inventory which did not meet our specifications and $(11,773)K recorded in September 2007 to write off four finished lots of our Thymoglobulin inventory which did not meet our specifications. (3) Includes a charge of $(64,000)K recorded in June 2007 to settle the litigation related to the consolidation of our former tracking stocks. (4) Includes a charge of $(25,000)K for an upfront milestone payment paid to Ceregene Inc. in June 2007 for the development and commercialization of certain gene therapy products. (5) Includes charges for the purchase of in-process research and development of $(106,350)K related to our acquisition of Bioenvision, Inc. in October 2007 and $(552,900)K related to our acquisition of AnorMED Inc. in November 2006. (6) Represents the write off of the goodwill related to our Genetics reporting unit in September 2006 in accordance with FAS 142, "Goodwill and Other Intangible Assets." (7) Includes charges of $(570)K for the three months ended and $(21,102)K for the year ended December 31, 2007 related to our completion of the first step of the two step process under which we acquired Bioenvision. In July 2007, we acquired approximately 22% of the outstanding shares of Bioenvision common stock on an as-converted basis, including all of the outstanding shares of Bioenvision preferred stock for $(72,229)K of cash. Subsequently, in October 2007, following a favorable merger vote by Bioenvision's shareholders, we completed the second step of the acquisition and, effective October 23, 2007, acquired the remaining outstanding shares of Bioenvision common stock for $(245,055)K of cash. In the fourth quarter of 2007, we also paid $(11,975)K of cash for the outstanding options to purchase shares of Bioenvision common stock. The full purchase accounting for the acquisition of Bioenvision, including the impact of the second step, is reflected in our consolidated financial statements for the three months and year ended December 31, 2007 and as of December 31, 2007. (8) For the year ended December 31, 2007, includes a pre-tax gain of $10,848K recorded on the sale of our entire investment in the common stock of Therapeutic Human Polyclonals Inc. in March 2007, which had a zero cost basis. For the year ended December 31, 2006, includes pre- tax gains of $69,359K related to the liquidation of our investment in the common stock of Cambridge Antibody Technology Group plc in May and June 2006. (9) Includes charges totaling $(5,735)K recorded in December 2007 to write off costs associated with the manufacture of tolevamer at our manufacturing facilities in Ireland and the United Kingdom. (10) All periods except for the three months and year ended December 31, 2006, reflect the adoption of Emerging Issues Task Force Issue No. 04-8, "The Effect of Contingently Convertible Debt on Diluted Earnings Per Share," or EITF 04-8. As a result of the adoption of EITF 04-8, the 9,686K shares issuable upon conversion of our $690.0 million in principal of 1.25% convertible senior notes, which were issued in December 2003, are now included in diluted weighted average shares outstanding for purposes of computing diluted earnings per share, unless the effect would be anti-dilutive. In accordance with EITF 04-8, interest and debt fees related to these notes of $1.9 million, net of tax, for the three months ended December 31, 2007 and $7.5 million, net of tax, for the twelve months ended December 31, 2007, have been added back to net income and 9,686K shares have been added to diluted weighted average shares outstanding for each of those periods for purposes of computing diluted earnings per share. For the three months and year ended December 31, 2006, excludes: (i) the dilutive effect of options, stock purchase rights and warrants to purchase shares of Genzyme Stock and (ii) the potentially dilutive effect of the assumed conversion of our convertible senior notes because the effect would be anti-dilutive due to our net loss for both of those periods. GENZYME CORPORATION (GENZ) Condensed Consolidated Balance Sheets December 31, December 31, (Unaudited, amounts in thousands) 2007 2006 Cash and all marketable securities $1,460,394 $1,285,604 Other current assets 1,629,820 1,377,437 Property, plant and equipment, net 1,968,402 1,610,593 Intangibles, net 2,964,810 2,790,819 Other assets (1) 265,282 126,735 Total assets $8,288,708 $7,191,188 Current liabilities $1,462,059 $651,439 Noncurrent liabilities (1) 186,399 879,038 Stockholders' equity 6,640,250 5,660,711 Total liabilities and stockholders' equity $8,288,708 $7,191,188 (1) Other assets as of December 31, 2007 includes $109,221K of net deferred tax assets, as compared to net deferred tax liabilities of $10,909K as of December 31, 2006, which were included as a component of noncurrent liabilities. GENZYME CORPORATION RECONCILIATION OF GAAP TO NON-GAAP EARNINGS Year to Date as of December 31, 2007 (Amounts in thousands, except per share data) Dilution Due to Gain on Common Invest- Litig- Stock ments ation Mile- Manufact Equiv- in Equity Settle- stone -uring NON-GAAP alents Securities ment Payment Related Income Statement Classification: Total revenues $3,813,519 Cost of products and services sold $(880,737) $(20,916) Selling, general and administrative $(1,016,066) $(64,000) Research and development $(641,388) $(25,000) Amortization of intangibles $- Purchase of in-process research and development $- Equity in income (loss) of equity method investments $23,548 Minority interest $101 Gains (losses) on investments in equity securities $2,219 $10,848 Other $(1,383) $(5,735) Investment income $70,196 Interest Expense $(12,147) Summary: Income (loss) before income taxes $1,357,862 $ - $10,848 $(64,000) $(25,000) $(26,651) (Provision for) benefit from income taxes $(417,932) - (2,698) - 9,069 9,702 Net income (loss) $939,930 $ - $8,150 $(64,000) $(15,931) $(16,949) Net income (loss) per share: Basic $3.56 $ - $0.03 $(0.24) $(0.06) $(0.06) Diluted (1) $3.47 $(0.09) $0.03 $(0.23) $(0.06) $(0.06) Weighted average shares outstanding: Basic 263,895 Diluted (1) 271,081 9,686 Acquisition Amortization FAS 123R Effect of GAAP Related Expense FIN 46 As Reported Income Statement Classification: Total revenues $3,813,519 Cost of products and services sold $(25,677) $(927,330) Selling, general and administrative $(106,172) $(200) $(1,186,438) Research and development $(58,101) $(7,461) $(731,950) Amortization of intangibles $(201,105) $(201,105) Purchase of in-process research and development $(106,350) $(106,350) Equity in income (loss) of equity method investments $(19,150) $(830) $3,830 $7,398 Minority interest $3,831 $3,932 Gains (losses) on investments in equity securities $13,067 Other $(7,118) Investment income $70,196 Interest Expense $(12,147) Summary: Income (loss) before income taxes $(125,500) $(201,935) $(189,950) $- $735,674 (Provision for) benefit from income taxes 15,781 72,449 58,148 - (255,481) Net income (loss) $(109,719) $(129,486) $(131,802) $- $480,193 Net income (loss) per share: Basic $(0.41) $(0.49) $(0.50) $- $1.82 Diluted (1) $(0.39) $(0.46) $(0.47) $- $1.74 Weighted average shares outstanding: Basic 263,895 Diluted (1) 280,767 (1) Non-GAAP basic and diluted earnings per share reflects the sum of the quarterly Non-GAAP diluted earnings per share activity for Q1-Q4 2007. (2) GAAP As-Reported diluted earnings per share and diluted weighted average shares outstanding reflect the adoption of EITF 04-8. In accordance with the provisions of EITF 04-8, interest and debt fees related to our 1.25% convertible senior notes of $7,543K, net of tax, have been added back to net income and approximately 9,686K shares have been added to diluted weighted average shares for purposes of computing GAAP As-Reported diluted earnings per share. GENZYME CORPORATION RECONCILIATION OF GAAP TO NON-GAAP EARNINGS For the Three Months Ended December 31, 2007 (Amounts in thousands, except per share data) Dilution Due to Common Stock Manufacturing Acquisition NON-GAAP Equivalents Related Related Income Statement Classification: Total revenues $1,036,758 Cost of products and services sold $(246,377) $(9,143) Selling, general and administrative $(284,297) Research and development $(178,460) Amortization of intangibles $- Purchase of in-process research and development $- $(106,350) Equity in income (loss) of equity method investments $9,319 Minority interest $- Gains (losses) on investments in equity securities $(969) Other $(1,493) $(5,735) Investment income $18,509 Interest expense $(2,864) Summary: Income (loss) before income taxes $350,126 $- $(14,878) $(106,350) (Provision for) benefit from income taxes $(100,918) $- $5,428 $8,819 Net income (loss) $249,208 $- $(9,450) $(97,531) Net income (loss) per share: Basic $0.94 $- $(0.036) $(0.367) Diluted (1) $0.91 $(0.024) $(0.033) $(0.344) Weighted average shares outstanding: Basic 265,418 Diluted (1) 273,688 9,686 FAS 123R GAAP Amortization Expense As Reported Income Statement Classification: Total revenues $1,036,758 Cost of products and services sold $(7,137) $(262,657) Selling, general and administrative $(23,334) $(307,631) Research and development $(13,128) $(191,588) Amortization of intangibles $(51,804) $(51,804) Purchase of in-process research and development $(106,350) Equity in income (loss) of equity method investments $(830) $8,489 Minority interest $- Gains (losses) on investments in equity securities $(969) Other $(7,228) Investment income $18,509 Interest expense $(2,864) Summary: Income (loss) before income taxes $(52,634) $(43,599) $132,665 (Provision for) benefit from income taxes $19,985 $12,920 $(53,766) Net income (loss) $(32,649) $(30,679) $78,899 Net income (loss) per share: Basic $(0.123) $(0.116) $0.30 Diluted (1) $(0.115) $(0.108) $0.29 Weighted average shares outstanding: Basic 265,418 Diluted (1) 283,374 (1) GAAP As-Reported diluted earnings per share and diluted weighted average shares outstanding reflect the adoption of EITF 04-8. In accordance with the provisions of EITF 04-8, interest and debt fees related to our 1.25% convertible senior notes of $1,884K, net of tax, have been added back to net income and approximately 9,686K shares have been added to diluted weighted average shares for purposes of computing GAAP As-Reported diluted earnings per share. GENZYME 2008 GUIDANCE 2008 Guidance DESCRIPTION Ranges Renagel / Renvela $690 $700 Total Renal 800 815 Cerezyme 1,215 1,240 Fabrazyme 495 505 Myozyme 320 330 Aldurazyme 135 145 Total Therapeutics 2,325 2,385 Total Transplant 210 220 Synvisc 270 280 Total Biosurgery 490 505 Total Diag/Genetics 475 485 Total Other 260 270 TOTAL REVENUE $4,500 $4,700 **GROSS MARGIN approx. 77% **SG&A approx. 27% **R&D approx. 17% Net Interest / Other approx. 60 TAX RATE - GAAP approx. 30% *TAX RATE - NON-GAAP approx. 31% GENZ GAAP EPS approx. $2.75 AMORTIZATION approx. $0.55 FAS123 EXPENSE approx. $0.60 CONTINGENT CONVERTIBLE DEBT approx. $0.10 **GENZ NON-GAAP EPS $4.00 ***WTD AVERAGE SHARES O/S approx. 274 CAPITAL EXPENDITURES approx. $500 

This financial guidance, which is provided as part of a press release dated February 13, 2008, 2008, is subject to all of the qualifications and limitations described therein. Actual results may differ from these forward- looking statements due to the numerous factors described in the press release.

 *Non-GAAP tax rate excludes the impact of amortization, one-time events, FIN 46, FAS123 expense and EITF 04-08. **Non-GAAP excludes the impact of amortization, one-time events, FIN 46, FAS123 expense and EITF 04-08. ***WTD Average Shares Outstanding excludes the impact of EITF 04-08. 

CONTACT: Media, Bo Piela, +1-617-768-6579, or Investors, Patrick Flanigan,+1-617-768-6563, both of Genzyme Corporation

Web site: http://www.genzyme.com/

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Latest Pharma News…

Source: Genzyme Delivers Strong Fourth Quarter to Conclude Outstanding Year

Waltham, MA June 3, 2004–The Massachusetts Medical Society (MMS) announced today that the organization will expand beyond its role of simply raising awareness of the poor state of men’s health to one of identifying specific prevention and treatment strategies to improve men’s physical, psychological, and emotional health.

Citing such facts as one in five men will suffer a heart attack before age 65, that nine out of 10 fatal workplace accidents claim the lives of men, and that men account for four out of five suicides, the Medical Society’s Committee on Men’s Health is bringing a new focus to the subject of men’s health. It seeks to educate primary care providers, family physicians, and mental health professionals about the need to improve the diagnosis, treatment and maintenance plans for their male patients. Among the topics to be addressed at this year’s symposium are substance abuse, cardiovascular disease, prostate cancer, men and domestic violence, psychological development, erectile dysfunction, and psychosocial issues of gay men.

The 2nd Annual Massachusetts Medical Society Symposium on Men’s Health, to take place Wednesday, June 16 at the Society’s Waltham Headquarters, is a full-day event and one of many continuing medical education programs offered by the Massachusetts Medical Society for physicians and health care professionals. The Society’s first conference on men’s health occurred last year, to call attention to the critical condition of men’s health in America.

Highlighting the 2004 symposium is keynote speaker Randall W. Maxey, M.D., Ph.D., president of the National Medical Association (NMA), the nation’s oldest and largest organization representing African American physicians and health professionals and the voice of more than 25,000 African American physicians and their patients. Dr. Maxey, a nephrologist in private practice in Los Angeles, will speak to the issue of ?Eliminating Disparities in Health Care.?

The issue of men’s health came to the forefront some four years ago with a national survey by Harris and Associates for The Commonwealth Fund, a private health research foundation. The survey discovered that one-fourth of men didn?t see a physician in the year prior to the survey, three times the rate for women, and that one-third of men didn?t have a regular doctor to see when sick or in need of medical advice. A year later, the Centers for Disease Control published findings that said men make fewer visits to physicians, hospital outpatient and emergency departments than do women.
   

The significance of the findings were clear: that a “disconnect” exists between men and the health care system. Thus, men often don?t get or don’t seek preventive care for potentially life-threatening conditions so common in men 40 and older, such as hypertension, heart disease, diabetes, colon and prostate cancer.
   

The Massachusetts Medical Society, with more than 18,000 physicians and student members, is dedicated to educating and advocating for the physicians and patients of Massachusetts. Founded in 1781, the MMS is the oldest continuously operating medical society in the country. The Society owns and publishes The New England Journal of Medicine, the Journal Watch family of professional newsletters, and AIDS Clinical Care, and produces HealthNews, a consumer health publication. For more information, visit www.massmed.org.

Source: Massachusetts Medical Society to raise awareness of men’s health issues

OREM, UT September 23, 2004 — Beehive Homes a provider of elderly assisted living care in home sized facilities has been servicing Utah for the last 14 years. What started out as a care home for mom, has blossomed into more than 30 homes throughout Utah and over 100 homes throughout 16 states as far reaching as Indiana.

Resident comments
“In 1989, she went to bed and there she stayed… now she eats solid food three times a day at the table with others… she is now interacting… this is amazing. She is staying up most of the day and sleeping all night, truly outstanding!” -Timothy C. Huitt
“Bee Hive was like a family. It made a difference to grandma. They all went out to make her feel wanted.” -Mr. & Mrs. Lavell Rich
Utah director Dennis Toland states, ?The communities say that mom is now ready for a little extra help??

Help is exactly what the doctor ordered. Beehive recently added its first ?skilled care home? to their success as healthcare providers. Same homestyle atmosphere, same privacy in private bedrooms, same family feeling, now add a Registered Nurse posing as a ?house mom? in charge of medicines and treatments, a rehab team as ?home fitness trainers?, and social work staff to drop by as the ?bedside neighbor?.

This new home seems to answer the ?call light? for neighborhood care centers. Providing services for skilled nursing and rehabilitation, and terminal illness care for hospice residents.

More skilled homes are scheduled for construction in the near future making this ?Beehive? very busy.

For more information on the new Beehive Skilled Care Homes visit www.beehivecomfortcare.com or call 1-801-223-4344

Source: ?The buzz in neighborhood nursing home care?

Peter Suber over at Open Access News has already weighed in on the petition to free up access to the Cochrane Library in Canada (and pointed to relevant links). First, let me say that I am for equity of access to information regardless of one’s ability to pay for that access.

But what I find ironic is how ideological (and sterile) this debate about access is becoming. We have publishers on the one hand fighting tooth and nail to hold researchers to old scholarly communication channels; on the other, many open access (OA) advocates automatically assume everything can/should be openly accessible.

That said, I agree with Ben Toth, Director of Health Perspectives and former Director of the NHS National Knowledge Service. Let’s deal with this issue in a logical fashion, not one resource (and petition) at a time. The question is not whether it would make better sense to have free access to the medical evidence. Of course it would; but my impulse is that as a medical community (and society) we do not want to deal with access issues by negotiating with publishers (however altruistic) one painful resource at a time. Throw open the gates, I say, and let’s pay with our taxes.

Not everyone in our society, however, is altruistic or ready to dismantle the capitalist model inherent in publishing. Big questions, for me, include whether the Canadian petition makes sense from two perspectives. First, what is the evidence we need Canada-wide access to Cochrane? Most academics and clinicians have access to Cochrane already. Is this drastic measure a way to ensure consumers read Cochrane?

Second, what makes the Cochrane Library any more important for Canadian consumers than access to primary research articles, including those at major journals? The last time I looked, Cochrane did not cover a lot of important health problems and did not have the range of coverage that would suit an entire population.

Of course, there are other questions. Yes, access to the best medical evidence in the Cochrane Library can be extremely useful for clinicians; in fact, it is widely used around the world, and access is plentiful in developing countries. But is Canada-wide access really what we need??

Then, there is the question whether Cochrane is widely used by medical professionals to make decisions for patients. How often? What disciplines? Some recent research suggests that Cochrane is not used all that much.

Does the petition hope to address issues like those described in that article? Would open access to the Cochrane Library encourage broader use and implementation at clinical frontlines in Canadian hospitals? Some tough questions for me to ponder, over the weekend. - Dean Giustini, OM blogger

Source: More Use of ‘Cochrane’ Through Canada-Wide Licensing?

(Ivanhoe Newswire)  Veterans with Post Traumatic Stress Disorder (PTSD) are just as likely to have long term health problems as people with chronic disease risk factors like high white blood cell counts.  However, very few healthcare providers screen PTSD patients for these biological markers.

“Exposure to trauma has not only psychological effects, but it can take a serious toll on a person’s health status and biological function as well,” said Geisinger Health Systems Senior Investigator Joseph Boscarino, PhD, MPH.  “PTSD is a risk factor for disease that doctors should put on their radar screens.”

Geisinger is organizing a national conference scheduled for May 13 to address PTSD in combat veterans from rural parts of the country.  But PTSD can also be experienced by people who’ve survived any traumatic event like an accident or natural disaster.  All of its victims are predisposed to biological risk factors.

In this study Boscarino, a Vietnam veteran examined the health status of 4,462 male Vietnam-era veterans 30 years after their military service.  The results showed that PTSD sufferers had an elevated white blood cell count which is a risk factor for disorders like leukemia.  The study also showed that veterans with high rates of inflammation were at risk. Another possible indicator was serious neuroendocrine problems.

Blood tests are used to screen for disease markers but PTSD is measured with a psychological test or a mental health examination.  Boscarino says that although it doesn’t have to be extensive, PTSD patients should get therapy as soon as possible.
“As the conflicts in the Middle East continue, we’re seeing a new wave of our service members who have posttraumatic stress.  If we don’t get these personnel help earlier, our research shows that they may experience more health problems down the road.

Source: Post Traumatic Stress Is a Risk Factor for Chronic Disease

Contains brief nudity and sexually suggestive material.

This is very long, but if you are at home bored on Valentine’s day, you might as well watch it.

Source: The Human Animal: The Biology of Love [Greg Laden’s Blog]

FDA advises health care practitioners to switch suppliers and limit use of drug until problem identified

ROCKVILLE, Md., Feb. 11, 2008–The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high “bolus” doses of the drug.

Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock. Four people have died after receiving heparin, although the relationship to the drug is unclear.

Heparin sodium is derived from pig intestines and has been marketed in the United States since the 1930s. Millions of patients benefit from the intravenous administration of this drug every year to avoid potentially life-threatening blood clots in the veins, arteries, and lungs.

“FDA concurs with Baxter’s decision to halt manufacture of heparin sodium in multiple-dose vials,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research. “FDA is vigorously investigating to determine the root cause of these serious reactions associated with the use of heparin made by Baxter. In the meantime, patients and health care professionals who cannot obtain alternative sources of heparin should use caution in administering any Baxter multiple-dose vials that remain.”

Heparin is commonly used before certain types of surgery, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis. In some situations, heparin treatment is initiated using a high bolus dose given directly into the bloodstream (intravenously) over a short period of time, usually less than one hour. The reported adverse events occurred in patients who were given heparin in this form of administration. There are many other uses of heparin involving lower doses or administration over a longer period of time; adverse events have not been seen with those uses.

About 350 adverse events associated with the Baxter product have been reported since the end of last year compared to less than 100 reports in 2007. Most of the events have taken place at hemodialysis centers, almost exclusively involving patients receiving a bolus dose – which is a high dose administered over a short time. While most of the reports involve multiple-dose vials, several cases include patients who received a bolus dose after their health care professional combined heparin from single-dose vials.

The Missouri Department of Health and Senior Services first notified the Centers for Disease Control and Prevention (CDC) in January of several severe allergic-type reactions to heparin that occurred at a single pediatric hospital beginning in November. The CDC in turn alerted FDA and Baxter, prompting the company’s voluntary recall of nine lots of heparin on Jan. 17.

Since then, FDA has learned of adverse events that extend beyond the recalled lots and involve patients receiving heparin for other purposes besides hemodialysis. Recent cases have included patients undergoing cardiac surgery and a specialized blood cell treatment known as photopheresis.

Over one million multiple-dose vials of heparin are sold per month in the United States; half of the vials are manufactured by Baxter of Deerfield, Ill. FDA is currently investigating whether similar events have been seen with other heparin manufacturers.

Physicians, dialysis center staff and health care providers are advised to use an alternate source of heparin or another blood-thinning drug when possible. When only Baxter product is available:

Administer the heparin as an infusion (not a bolus) whenever possible.
Use the lowest dose necessary at the slowest infusion rate acceptable to obtain the desired clinical effect.
Closely monitor the patient for adverse events, particularly hypotension and signs and symptoms of hypersensitivity and ensure that resuscitation equipment is available.
Consider pretreatment with corticosteroids (cortisone type medicines) or antihistamines (drugs that relieve the symptoms of allergic reactions) although it is not known if such pretreatment is effective.
Any allergic-type reaction to heparin infusion should be reported to FDA’s MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, M.D. 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

#

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Karen Riley, 301-827-6244
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FDA Public Health Advisory
Important Warnings and Instructions for Heparin Sodium Injection (Baxter)

The Food and Drug Administration is issuing this alert to:

• inform the public about reports of serious adverse events in patients who received bolus injections of heparin sodium for injection primarily from multiple-dose vials manufactured by Baxter Healthcare Corporation, and to
• recommend measures that may help to minimize these risks if this product must be used due to medical necessity. 

Heparin sodium is an anticoagulant (blood thinner) that is commonly administered intravenously.  It is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis (DVT) and pulmonary emboli.  In many settings heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus (over a short period of time, usually a few minutes). Serious adverse events have recently been reported in patients who received these higher bolus doses.  The serious adverse events include allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension requiring treatment.  Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded..  The reports have largely involved use of multiple-dose vials.  However there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. 

Heparin is also used in other clinical settings at lower doses or over longer periods of time; adverse events like those described above have not been seen with those uses.  FDA is currently investigating whether similar adverse events have been reported for heparin products from other manufacturers. 

Because of concern about the occurrence of these serious adverse events, Baxter has temporarily suspended manufacture of its multiple-dose vials of heparin sodium pending the completion of an extensive ongoing investigation to determine the root cause of the problem.  Heparin is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug.  Therefore, Baxter and FDA agree that multiple-dose vials of heparin manufactured by Baxter that are currently in distribution will not be recalled.  These vials may be used with caution in situations where alternative products are either not available or would be inappropriate for the individual medical situation. 

FDA is providing the following recommendations to physicians, dialysis center staff, and other health care providers when using heparin sodium for injection.

• When bolus use is required, try to use a heparin product from another manufacturer or an alternate anticoagulant
• When Baxter product is the only heparin product available and use of heparin is considered to be medically necessary:
  • Administer infusions without using a bolus dose whenever possible
  • Use the lowest dose necessary at the slowest infusion rate acceptable to obtain the desired effect 
  • Closely monitor the patient for adverse events, particularly hypotension and signs and symptoms of hypersensitivity, and ensure that resuscitation equipment is available.
  • Consider the potential risks and benefits in individual patients of pretreatment with corticosteroids or antihistamines before the heparin is administered.  At this time FDA does not have data to determine if such pretreatment is effective.

Heparin sodium is a pork-derived product that has been marketed in the United States for nearly 70 years.  It is estimated that over 1 million multiple-dose vials of heparin are sold per month in the U.S., about half of which are manufactured and distributed by Baxter Since late December 2007 Baxter and FDA have received nearly 350 reports of adverse reactions, and about 40% of the cases are estimated as serious, based upon preliminary and ongoing review.  The number of reports seen in the past two months is a marked increase from the number of reports associated with heparin use normally received in a similar time period. 

The majority of reported events occurred at hemodialysis centers.  In early January, 2008, clusters of these allergic adverse event reports came to the attention of the CDC and to Baxter.   Available data at that time suggested a link of these cases to product from specific heparin manufacturing lots.  This resulted in Baxter recalling 9 product lots on January 17, 2008.   FDA initiated inspections of Baxter’s U.S. manufacturing plant and processes the same day.

Since the January product recall, new reports indicate that adverse events are not limited to only the recalled heparin lots.  Baxter and FDA have learned of cases occurring in hospitals where heparin was used during cardiac surgery and in patients undergoing photopheresis.  Like the events associated with dialysis, most have resolved with medical management.  Four patients have died since these adverse events were noted; the relationship between the deaths and the heparin use is not certain.   

The underlying cause for the abrupt increase in the number of adverse events reported for Baxter’s heparin sodium is under investigation.   FDA inspectors and scientists are working independently and in collaboration with the Centers for Disease Control and Baxter to discover the underlying cause of the adverse events.  FDA personnel and laboratories are conducting intensive inspection and testing related to Baxter’s heparin sodium.  FDA is also seeking advice from outside experts in the manufacture and clinical use of heparin in order to help guide our investigation.  

FDA continues to monitor its post-marketing safety database for additional cases and has initiated contact with international regulators to determine whether similar events have been seen in other countries with similar products.    Health care providers should report any allergic-type reaction to heparin infusion to FDA’s MedWatch on line at http://www.fda.gov/medwatch/report/hcp.htm ,  by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.

Questions and Answers on Heparin Sodium Injection (Baxter)

1. What is FDA announcing?

FDA is announcing recent reports of serious allergic-type hypersensitivity reactions and cases of severe hypotension in association with the use of intravenous bolus doses of heparin sodium for injection manufactured by Baxter.  In order to minimize the risks associated with use of this product, FDA is providing recommendations to physicians and healthcare providers to avoid bolus dosing with Baxter heparin whenever possible and recommendations for strategies that may limit the occurrence or severity of adverse reactions if the use of heparin is medically necessary and Baxter heparin is the only heparin product available

  2. What products and what patients will be affected by this?

Products affected are:  Baxter’s Heparin Sodium Injection multiple-dose vials (1000 units/mL concentration, 10 mL and 30 mL vials; 5000 units/mL concentration, 10 mL vials; and 10,000 units/mL, 4 mL vials).  These are used when patients need large intravenous doses given quickly, sometimes called “bolus doses” in order to thin their blood over a very short period of time.  Patients affected are:  patients with kidney failure on hemodialysis; patients undergoing certain types of cardiovascular surgery; patients undergoing other specialized treatments called photopheresis and plasmapheresis and some patients who have blood clots in arteries or veins.

3. Are there other patients who may be treated with heparin that this will not affect?  (small dose, flush, etc.)

Heparin is used in many other medical settings, but these do not usually require the higher doses that are of concern with the Baxter product.  Other uses which are not of concern include small doses of heparin used to flush, or clear out, intravenous catheters or to prevent clotting in indwelling catheters, and slow heparin infusions to treat clotting in various hospital settings.

4. What other companies make heparin and is FDA sure that their product(s) do not have the same risk?

Heparin sodium in multiple dose vials is also manufactured by APP Pharmaceuticals.  Hospira and B. Braun also supply some heparin sodium for injection:  Hospira in single-use syringes, vials and bags and B. Braun in pre-mixed bags for infusion.  FDA is currently investigating whether similar adverse events have been reported for heparin products from other manufacturers. 

5. Is APP Pharmaceuticals able to provide enough heparin to avoid a shortage?

Baxter currently manufacturers about 50% of the heparin sodium used in the U.S.  Since manufacture of Baxter’s multiple-dose heparin sodium vials, which accounts for approximately 75% of Baxter’s heparin production, is being suspended, there is a real potential for a shortage of heparin sodium for bolus dosing, especially in the short term.  FDA is working with APP and other manufacturers (outside the US) to increase production and/or provide alternate sources of heparin sodium.

6. What kinds of serious adverse events have occurred?  How many?

From mid-December 2007 through January 2008 Baxter has received 350 reports of adverse events reported with their product, many of them serious.  These include severe allergic reactions, severe nausea, vomiting, diaphoresis, difficulty breathing, and very low blood pressure.   Four patients who received heparin bolus during this time died; the relationship between heparin and these deaths is uncertain.

7. When did FDA learn about the adverse events? 

FDA learned of the occurrence of adverse events on January 9 from CDC investigators who were evaluating small clusters of these events in dialysis centers.  On January 16, 2008, FDA initiated an inspection of Baxter’s manufacturing plant in Cherry Hill, New Jersey.  At the time of the inspection, Baxter notified the Agency that nine lots of its heparin sodium were being recalled due to an increase in the rate of adverse events with these lots. The recall was initiated on January 17, 2008. 

8. Why is FDA not taking the Baxter heparin off pharmacy and hospital shelves, but instead is allowing them to use what product they have?

Heparin sodium is a medically necessary product with some uses for which there are no well-established substitutes.  Abrupt withdrawal of all Baxter heparin product would likely lead to severe shortage of heparin sodium for all uses.  The increase in occurrence of adverse events with Baxter’s heparin appears to be related to administering large amounts of the heparin product over a very short time. An increase in serious reactions has not been seen with use of small amounts and/or slow infusions of heparin sodium.  Therefore, the Agency has determined that in the short term, with measures being undertaken to advise caution and careful monitoring of patients receiving heparin, the public health is best served by continued availability of Baxter’s existing heparin sodium for clinical situations in which it is needed.  The Agency is working with heparin sodium manufacturers to identify and ensure adequate supplies of heparin sodium for future clinical use.     

9. What is the cause of the adverse events?  What is FDA doing to learn more?  When will results of investigations be available?

At this time the cause of the adverse events is unknown.  FDA has been working with Baxter and independently to investigate the root cause of the problem since it was first identified and led to the January 17th limited recall.  We will continue intensive and in-depth investigation and testing to determine the root cause of the problem.

10. Why did FDA not require Baxter to take this measure at the time of their first recall?

In January it appeared that the adverse events being reported were linked only to a small number of manufacturing lots of Baxter’s heparin sodium.  Therefore, only those lots were recalled (taken off of hospital and facility pharmacy shelves).   However, serious adverse events continued to be reported at an increased rate and involved additional lots of heparin sodium.    

11. What other products does Baxter sell?  Are any of those products having similar problems?

Baxter sells a wide variety of pharmaceutical products used to treat a number of medical disorders.  We have no evidence that the company’s other products are associated with an increase in adverse events

12. How is FDA investigating this problem?

We are investigating all possible sources of the problem, including evaluating the active pharmaceutical ingredient manufacturing facility, located in China, and finished dosage form manufacturing facility, located in New Jersey.  We will be inspecting these facilities as soon as possible.  In addition, FDA is performing comprehensive laboratory analysis of the heparin.  FDA is collaborating with the CDC and other experts to determine the root cause of the problem.  FDA is also working closely with its international counterparts, in case they have any relevant information

13. What are the alternatives to using the Baxter product?

Heparin sodium in multiple dose vials is also manufactured by APP Pharmaceuticals.  Hospira and B. Braun also supply some heparin sodium for injection:  Hospira in single-use syringes, vials and bags and B. Braun in pre-mixed bags for infusion.  There are other FDA approved anticoagulants, including low molecular weight heparins and direct thrombin inhibitors; however, these products are not approved for use in all the same clinical settings as heparin.  There is no experience with the other anticoagulants to achieve the immediate anticoagulation needed for hemodialysis, phereses, and certain cardiac procedures.

14.  What should I do if there are no suitable alternative products and my health care provider cannot obtain heparin manufactured by APP?

FDA is recommending that providers consider administering heparin as an infusion rather than a bolus if at all possible.   If a heparin bolus is required, FDA recommends that providers use the lowest dose and administer at the slowest rate possible to achieve the desired effect.  FDA is advising physicians to monitor patients carefully during the infusion, particularly at the onset, for evidence of allergic reactions, and have resuscitation equipment readily available.  FDA is also advising physicians to consider the potential benefits and risks in individual patients of pretreatment with corticosteroids or antihistamines.  At this time FDA does not have data to determine if such pretreatment is effective.

15. I received the Baxter product in the past.  Am I at risk for a serious reaction?

The serious reactions have generally occurred rapidly; usually within minutes of when the bolus dose was started.  However, some patients undergoing cardiac procedures have developed very low blood pressures as late as an hour following the start of the heparin bolus.  There is no evidence that the product causes very delayed or late onset allergic reactions. 

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Source: Baxter’s Multiple-Dose Vial Heparin Linked to Severe Allergic Reactions