, September 24, 2008, by Damian J. Troise — Big pharmaceutical companies and their biotech cousins will likely weather the financial crisis engulfing Wall Street, several analysts said, because of the necessity of their products and cash-rich balance sheets.

While drug developers’ shares have been dragged down over the last week, they are still slightly stronger than the broader market. Since the market opened Sept. 15, the American Stock Exchange’s pharmaceutical and biotechnology indexes are down 3.6 percent and 3.7 percent, respectively.

Meanwhile, the Dow Jones Industrial average is down 4.7 percent and the Standard & Poor’s 500 index has lost 4.8 percent.

Many of the larger, established drug developers have diversified balance sheets that have cut down their reliance on credit and tools such as commercial paper, which is short-term debt used to finance working capital.

“If there’s a flight to safety (by investors), these guys are the safest around,” said Standard and Poor’s analyst Arthur C. Wong.

The falling broader market so far has had little impact on several multibillion-dollar buyout bids within the industry. Late Monday, Bristol-Myers Squibb Co. increased its unsolicited offer for cancer drug partner ImClone Systems Inc. to $4.7 billion, or $62 per share.

The previous $60-per-share offer was rejected by ImClone, and going into Tuesday the company’s stock climbed $3.10, or 5.2 percent, to $62.50, indicating that investors believe they can get more money for the company. ImClone previously said it was offered $70 per share, but has not named the prospective buyer.

Elsewhere in the sector, Genentech Inc. has already rejected a $43.7 billion bid by Roche, which owns nearly 56 percent of the company. Genentech said it was open to a higher bid. Alpharma Inc. already said no to a $1.4 billion offer from rival King Pharmaceuticals Inc.

“I don’t think the market has gotten to the point where it will be prohibitive for them to close the deals,” said Morningstar analyst Damien Conover. “They have a lot of cash on the balance sheets and their credit quality is very strong.”

While these potential blockbuster buyout deals continue to play out, smaller biotechnology companies still remain attractive targets as big pharma tries to build up their research and development pipelines. The market downturn has not detracted from those smaller companies’ leverage in negotiating licensing and buyout deals.

“More acquisitions are likely heading into the 2011 to 2012 patent cliff,” said Moody’s Investors Service Senior Vice President Mike Levesque, referring to the period when many companies expect key revenue-driving drugs to lose patent protection and face generic competition.

“As we get closer and closer to these years, its likely to accelerate,” he said.

The Wall Street Journal, September 24, 2008, by Jennifer Corbett Dooren – Certain lung-disease medications such as Boehringer Ingelheim GmbH’s Spiriva are associated with an increased risk of cardiovascular death, heart attack and stroke, according to an analysis released Tuesday.

The analysis, being published in this week’s Journal of the American Medical Association, looks at a class of medications known as inhaled anticholinergics that are used to treat chronic obstructive pulmonary disease. Spiriva, a drug co-marketed by Pfizer Inc. with more than $2 billion in global sales last year, is the dominant anticholinergic medication. It works by blocking a chemical involved with airway restriction. The analysis also looked at ipratropium, an older medication also marketed by Boehringer Ingelheim under the brand name Atrovent.

Chronic obstructive pulmonary disease refers to a group of lung conditions such as emphysema and chronic bronchitis that cause a narrowing of airways in the lungs, making it hard to breathe, according to the National Institutes of Health. COPD is the fourth leading cause of death in the U.S.

The research was led by doctors at Wake Forest University School of Medicine in North Carolina.

Boehringer Ingelheim and Pfizer said new data from a four-year, 6,000-patient study involving Spiriva showed there was no increased risk of heart attack, stroke or death from any cause. The full results of that study, called Uplift, won’t be released until next month.


Drugs for lung disease may increase heart attack risk

USA Today (9/24, Rubin) reports that “widely prescribed drugs recommended as first-line therapy for chronic obstructive pulmonary disease, or COPD — the USA’s fourth-leading killer — raise the risk of heart attacks, strokes, and death from heart disease,” according to a study published in the Sept. 24 issue of the Journal of the American Medical Association. COPD comprises “two incurable lung ailments, chronic bronchitis and emphysema. Most COPD patients have both. The most common cause is cigarette smoking.”

The study focuses on “a class of medications known as inhaled anticholinergics that are used to treat” COPD, the Wall Street Journal (9/24, B2, Dooren) adds. For instance, Spiriva (tiotropium), co-marketed by Boehringer Ingelheim GmbH and Pfizer, Inc., “is the dominant anticholinergic medication,” which “works by blocking a chemical involved with airway restriction. The analysis also looked at ipratropium, an older medication also marketed by Boehringer Ingelheim under the brand name Atrovent.”

According to the AP (9/24, Tanner), Sonal Singh, M.D., M.P.H., of the Wake Forest University School of Medicine in Winston-Salem, N.C., and colleagues, conducted a meta-analysis of “17 randomized studies comparing mostly older patients on either of the drugs with those on different medicine or dummy drugs.” The researchers found that “using either drug for more than one month appeared to increase chances for fatal and nonfatal heart problems, including heart attacks, by more than 50 percent.” In addition, of “7,400 patients on either inhaled drug, 1.8 percent, or 135 people, developed fatal or nonfatal heart problems over a period of several weeks to several years.” Conversely, “among about 7,300 patients on other drugs or dummy medicine, 1.2 percent, or 86, had those problems.”

The authors pointed out that “a larger clinical trial is needed to validate the findings,” Bloomberg News (9/24, Ostrow) reports. Still, in light of these findings, “patients with prior heart attacks and strokes, or those who have high blood pressure, may want to consider stopping these medicines, said Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York, who wasn’t involved in the study.”

HealthDay (9/23, Gardner) noted that “there have been previous scattered reports of an increased risk of cardiovascular events in people using Spiriva, resulting in an ‘early communication’ from the U.S. Food and Drug Administration earlier this year warning of a possible increased risk of stroke with use of the drug.”

A recent study conducted by Veterans Affairs researchers also “found a 34 percent increase in risk of cardiovascular death for newly diagnosed COPD patients using ipratropium,” MedPage Today (9/23, Peck) added. Meanwhile, the authors of the current study “said the precise mechanism by which inhaled anticholinergics increase risk was uncertain, but they noted that the Lung Health Study found ‘an increase in the incidence of supraventricular tachycardia with inhaled ipratropium consistent with the vagolytic nature of the drug.'” The researchers also acknowledged that “the study was limited by quality of the reported data, much of which came from small, short-term trials. Moreover, they said the reporting of cardiovascular outcomes might have been incomplete, because these were not the focus of those studies.”

In response to the results, “pharmaceutical industry spokespeople issued a statement strongly disagreeing with the conclusions of the study,” and presented “their own new analysis that they say confirms the safety of Spiriva,” WebMD (9/23, Doheny) reported.

The BBC (9/23), AHN (9/23), the U.K.’s Telegraph (9/23, Devlin), HeartWire (9/23, Stiles), the CBC (9/24), and the U.K.’s Press Association (9/24) also cover the story. – September 24, 2008 — Eli Lilly and Co. leads the pharmaceutical industry in its decision to disclose how much money it pays to individual doctors, nationally, for advice, speeches and other services.

The drug company’s move towards greater transparency, comes as members of Congress push a disclosure bill in an effort to prevent such payments from improperly influencing medical decisions.

Beginning next year, Eli Lilly will disclose payments of more than $500 to doctors for their roles as advisers and for speaking at educational seminars. In later years, the company will expand the types of payments disclosed to include such things as travel, entertainment and gifts.

Some have voiced concerns that doctors are influenced by these payments in their treatment decisions and that this in turn can drive up medical bills. Although most physicians believe that free lunches or trips have no effect on their medical judgment, research has shown that these type of payments can affect how people act.

“The ethical handwriting is on the wall. Disclosure is coming. States are pushing for it, and once a few states do, it’s hard to imagine the federal government won’t line up behind,” said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania in Philadelphia. “I think that’s a good thing because we have a great deal of empirical evidence that gift giving can influence behavior in terms of prescriptions, publishing positive findings but suppressing negative findings, and generating enthusiasm for new drugs.”

Eli Lilly was also the first drug company to publicly report its educational grants for medical conferences. Dr. John Lechleiter, president and CEO of the company, said that made good business sense for the drug industry.

“We’ve learned that letting people see for themselves what we’re doing is a good way to restore trust,” Lechleiter said.

In the past two years, lawmakers from both chambers of Congress introduced bills that would require drug and medical device manufacturers to disclose any payments to doctors exceeding $25, but the industry chafed at the strict reporting threshold. Eli Lilly had announced earlier that it intended to comply with key aspects of the legislation once some lawmakers in the Senate agreed to a higher reporting threshold of $500.

Scores of trade groups representing doctors, such as the American Medical Association, voiced their support for the legislation once it included the higher, $500 threshold. In a letter to lawmakers, the groups said the disclosures would “enhance the medical profession’s ability to provide oversight and strengthen our ability to serve as stewards of medicine.”

Eli Lilly’s disclosure of payments to doctors will begin in the second half of 2009, and will cover payments made in the first half of the year. The company doesn’t plan to report payments from 2008 or earlier, noting that the legislation before Congress also did not contemplate such a look back. Gradually, the company plans to expand its registry to incorporate all payments that the Physician Payment Sunshine Act would require to be made public.

Lechleiter said that physicians who advise the company or speak at conferences about their experiences in treating patients take time away from their medical practice. That’s why they need to be compensated at fair, market rates.

“We’re oftentimes taking them away from their practice for a day or more,” Lechleiter said. “It’s a service that they’re providing and they deserve compensation for that.”

A handful of states and the District of Columbia already have disclosure laws for payments from drug companies to doctors. Those states are Minnesota, Vermont, West Virginia and Maine. None of those states require disclosure of payments from medical device makers.

Dr. Peter Lurie, deputy director of the health research group at Public Citizen, said the state laws can let patients know when their doctors have a connection to a drug firm, but the state laws are not working very well. The laws have various exemptions and sometimes don’t even disclose the information to the public, he said.

Lurie was skeptical that Eli Lilly’s announcement represented a step forward on the issue of more transparency in health care.

“There are dozens of pharmaceutical companies. This is just one of them. Most won’t follow this guideline at all, and there will be no enforcement,” Lurie said. “This is Ely Lilly’s attempt to forestall the federal legislation by saying we’re in effect complying anyway.”

Public Citizen, a consumer advocacy group, also objects to the $500 threshold for reporting. Lurie said it should be much lower – $25 per gift.

“Most of what will wind up being disclosed is speaker’s fees, consulting and research grants,” Lurie said. “But most people want to know more than that. They want to know about meals, travel and that sort of thing. A lot of people will be cut out by the $500 annual limit.”

Sen. Charles Grassley, R-Iowa, applauded Eli Lilly’s announcement, but he said he would continue to push for legislation that requires disclosure of physician payments by drug and medical device manufacturers.

“Consumers and taxpayers deserve a federal requirement that applies to all kinds of payments to physicians in every state in the nation,” Grassley said.

Grassley’s bill calls for penalties of $1,000 to $5,000 for failure to report a payment, with an annual cap of $250,000 for knowingly failing to report. The legislation would pre-empt state reporting requirements.

The trade group, Pharmaceutical Research and Manufacturers of America, has expressed support for Grassley’s bill in the past.

Ken Johnson, senior vice president for the drug makers’ trade group, said payments to physicians are an important part of the effort to inform health care providers about such things as new treatment options, appropriate dosing and potential interactions with other drugs.

“We believe that improving transparency in such interactions is a laudable, but complex, goal,” Johnson said. “Any steps toward transparency should be structured in a way that would not chill these important exchanges.”

Under Lilly’s plan, the public will be able to access a listing of payments through an Internet database. The registry will be updated annually to reflect the previous year’s payment information.

September 24, 2008 – Teva Pharmaceutical Industries Ltd. said Tuesday the Food and Drug Administration approved its ProAir asthma medication for patients as young as 4 years old.

The albuterol sulfate inhaler, which is used to open up a person’s lungs during an asthma attack, is already approved for patients 12 years of age and older. Albuterol is commonly used in an array of asthma medications.

Shares of Israel-based Teva rose 34 cents to close at $44.61.

September 24, 2008 – The World Health Organization called for urgent action Wednesday to address public health risks posed by global warming to countries in the Asia Pacific, including a rise in diseases and food shortages.

Participants in a weeklong regional WHO conference in Manila are considering a draft proposal urging governments and international agencies to incorporate health concerns into plans to mitigate and adapt to climate change.

It says governments should undertake studies and promote awareness on the public health impact of global warming and boost measures to ease its effects, noting data have been limited, often inconsistent and seldom shared in a transparent manner.

WHO should also provide technical guidance and facilitate funds from donors for climate change and health-related programs in the region, it added.

The draft proposal cited the promotion of non-motorized transport systems, like bicycles, and the use of fewer private vehicles as examples of measures that could reduce greenhouse gas emissions and improve air quality.

Outgoing WHO regional chief Shigeru Omi told the conference Tuesday that climate change is among the top health challenges facing countries in the region, where cases of dengue, malaria and other diseases could jump.

“Rising oceans could soon threaten our low-lying island states and areas in the Pacific,” Omi said.

Global surface warming by 2090-2099 is projected to increase between 1.1 and 6.4 degrees Celsius (2 to 12 Fahrenheit), and the mean global sea level is projected to rise 30-60 (1-2 feet) by 2100, mainly due to thermal expansion of the ocean, the draft paper said.

That could expand the range of mosquitoes that carry malaria and dengue, threaten low-lying island states and cause heat waves and droughts that threaten food security, Omi warned.

“A warmer planet has contributed to some diseases, such as dengue, now occurring in areas where it was never seen before,” he said.

Exhibition Opens October 18, 2008, and Will Remain on View through August 16, 2009,
Before Traveling to Europe, Asia, the Middle East, Mexico, and South America


New York, July 8, 2008 — The American Museum of Natural History today announced a major new exhibition, Climate Change: The Threat to Life and A New Energy Future, that will examine one of the most pressing scientific issues of our time—the massive, human-induced warming of Earth, a phenomenon that could lead to drought, rising sea levels, heavy storms, and other events with potentially dire impacts on the health of society and the natural world. This exhibition will explore the science, history, and impact of climate change, and illuminate ways in which individuals, communities and nations can reduce their carbon footprints. Opening October 18, 2008, Climate Change will remain on view at the Museum until August 16, 2009, after which it will begin an international tour.

“Evidence has been accumulating for some time that Earth is warming due to human activity,” said Museum President Ellen V. Futter, “but we are only just beginning to come to terms with the breadth of the consequences of this phenomenon, and to learn what we can do to mitigate them. The fact is,” Ms. Futter continued, “we do have options; but implementing solutions will require individual, national, and global action. Climate Change will examine both the consequences of global warming and possible solutions to this critical problem.”

Climate Change will give visitors a scientific context to help make sense of today’s most urgent headlines on global warming. More importantly, the exhibition will inspire visitors to participate in the world-changing discussion on how best to reduce greenhouse gas emissions.

Human activity emits 29 billion tons of carbon dioxide each year from the burning of fossil fuels.
© Kenn W. Kiser

The central part of the exhibition will explore the effects of climate change on several separate but interrelated areas: Earth’s atmosphere, oceans, land, and polar ice sheets. Scientists have documented a dramatic increase in greenhouse gases in the atmosphere over the past 150 years—especially CO2 (carbon dioxide)—caused primarily by the burning of fossil fuels, deforestation, and other changes in land use. Climate Change will use realistic dioramas, hands-on activity stations, and dynamic animations to understand the climate’s response to the build-up of greenhouse gases and explore the repercussions for today’s world and future generations.

One activity allows visitors to investigate raising the sea levels on a dynamic scale model of Lower Manhattan to graphically illustrate the flooding that would be caused by the melting of ice sheets and warming of oceans. The movements of clouds, ocean currents and seasonal ice that reveal how climate works will be internally projected on digital video globes throughout the exhibition. A ghostly coral reef—a victim of “coral bleaching”—will show how increased CO2 in the oceans and higher water temperatures are killing corals and the communities that they anchor. And a six-foot-tall model that represents one ton of coal will provide a startling visual reminder of each visitor’s own carbon footprint: Scientists estimate that every person in the world burns, on average, the equivalent of three tons of coal every year. The exhibition will also explore the options for future energy sources—including coal-burning combined with a CO2 capture and sequestration, solar power, nuclear energy, and wind power.

Climate Change does more than examine a complex and immediate problem—it lays the groundwork for potential solutions, from the personal to the national and global, and shows how these are within our grasp. The exhibition will empower and encourage visitors of all ages to help address the climate change problem by reducing energy consumption in their daily lives, whether by buying energy-efficient appliances, growing their own food, switching to compact fluorescent bulbs, or choosing to walk or take mass transit to get to work or school.

Climate Change: The Threat to Life and A New Energy Future is organized by the American Museum of Natural History, New York, in collaboration with the Abu Dhabi Authority for Culture & Heritage, United Arab Emirates; The Cleveland Museum of Natural History; The Field Museum, Chicago; Instituto Sangari, São Paulo, Brazil; Junta de Castilla y León, Spain; Korea Green Foundation, Seoul; Natural History Museum of Denmark, Copenhagen; Papalote Museo del Niño, Mexico City, Mexico; and Saint Louis Science Center.

Climate Change: The Threat to Life and A New Energy Future is proudly presented by Bank of America. Major support has also been provided by the Rockefeller Foundation. Additional support for Climate Change and its related educational programming has been provided by Mary and David Solomon, the Betsy and Jesse Fink Foundation, the Linden Trust for Conservation, and the Red Crane Foundation.

The exhibition is curated by Edmond A. Mathez, Curator, Earth and Planetary Sciences, Division of Physical Sciences, American Museum of Natural History; and guest co-curated by Michael Oppenheimer, Albert G. Milbank Professor of Geosciences and International Affairs, Woodrow Wilson School, and the Department of Geosciences, Princeton University, New Jersey.