Life Science Compliance Update

July 03, 2014

State of the US Biopharmaceutical Industry 2014

APCO Worldwide and its research consultancy APCO Insight released its "State of the U.S. Biopharmaceutical Industry 2014". The report evaluates the industry's relationships, or "Return on Reputation (ROR)"—a metric developed by the firm—with key industry stakeholders.

In a release, APCO wrote: "The biopharmaceutical industry in the United States continues to have a positive reputation among key stakeholders, and there are opportunities for the industry to build upon their role as leaders on critical health care issues by going beyond stakeholders' expectations," said Chrystine Zacherau, senior director of health care research at APCO Insight. "In particular, stakeholders express a desire to see the industry play a larger role in working to address pressing, long-term public health issues and exceed expectations in the areas of sustainable innovation and disease awareness."

"This has been a pivotal time for the biopharmaceutical industry and greater health care industry in the United States," said Stig Albinus, global leader of APCO's health care practice. "The biopharmaceutical industry has stepped up to meet stakeholders' expectations over the past two years by being responsive to their concerns and working responsibly to improve health care. With the ROR Indicator, we can show senior communication and business leaders in the industry how they can continue to meet and exceed these expectations by better communicating about their innovative products and solutions to address some of society's long-term public health problems."

As previously reported by Medical Marketing & Media Online, the report found that the industry's score was relatively stable among most stakeholders, but cautioned of a trending decline among policy leaders. The group also raised concerns about responsible marketing, especially to physicians.

Researchers found a modest decrease, which it did not attribute any statistical significance to, in the group's "reputation index score" for HCPs and opinion leaders, as well as a slight tumble in the overall reputation index score from 61.3 in 2012 to 60.5 in 2013.

APCO Insight defines reputation index as a "reliable measure of the industry's overall reputation that takes into account" a number of factors including 54 "stakeholder-defined attributes," such as sustainable innovation, pharmacovigiliance, chronic disease management and patient assistance.

It also states that a "one-point increase" in "reputation index translates into," a .13% increase in market cap, 1.1% increase in sales for the average biopharma company and an increase of more than 550,000 patients who are likely to ask their doctor about a company's medicine, among others.

It was also noted that "concerns about responsible marketing persist—especially marketing to physicians—and elevate the importance of Responsible Business Operations." Given the recent widespread allegations of bribery by GSK in China, these concerns should come as little surprise.

October 15, 2010

The Miracle of Insulin

Insulin creator 
Today, only 1 out of 5,000 to 10,000 chemical compounds makes it to the pharmacy, and this process can take between eleven and twelve years, and can cost on average $1.3 billion. While significant breakthroughs in medicine and innovation in science occur each day, “only once or twice in a generation does a miracle drug” come about that changes the way humans live and physicians practice medicine. We often refer to these products as “blockbuster medications.”

Yet with so many advances occurring so rapidly, the New York Times pointed out that we often forget the “birth of the first” blockbuster medication: injectable insulin, which was “finally isolated in 1921 by a team of squabbling Canadians.” Fortunately, the public will have a chance to relive the birth of injectable insulin starting this week when the exhibition “Breakthrough: The Dramatic Story of the Discovery of Insulin” opens at the New-York Historical Society, 2 West 77th Street, New York, and continues through Jan. 31, 2011.

The exhibition tells the story of how New York City’s death rate from diabetes in 1921 was estimated to be the highest in the country. When insulin was introduced, although it was not a cure, it turned “a brief, deadly illness into a long, chronic struggle.” As Thea Cooper and Arthur Ainsberg explain in their book “Breakthrough,” on which the exhibit is based, what came next was a series of complicated questions that inevitably follow medical miracles: “Who will get the drug first? Who will pay for it? Who will make enough for everyone? And, of course, who will reward its developers as they feel they deserve?”

“Breakthrough,” tells the story of how half a dozen different research groups in the first decades of the 20th century “were hot on the trail of insulin, a hormone manufactured in the pancreas but difficult to separate out from the digestive enzymes also made there.” This discovery was significant because “without insulin the body is unable to use glucose, its primary fuel.” As the Times explains, when there is a lack of insulin, “sugar and starch in the diabetic’s diet turn into poison, clogging the bloodstream with unusable glucose: the glucose is eliminated in sweet-tasting urine as the body’s cells literally starve in the midst of plenty. Insulin-deficient patients are both thirsty and ravenous, but the more they eat, the faster they waste away.”

Before insulin was available, doctors were forced to put diabetics on “salad- and egg-based diets devoid of sugar and starch, with only the minimum number of calories needed to survive.” While this caused patients to become “skeletal, the excess glucose disappeared from their blood and urine, and they survived far longer than untreated contemporaries.”

When insulin was finally isolated in Canada at the University of Toronto by Frederick Banting and his assistant Charles Best in 1921, everything changed. Their discovery came while they were experimenting on diabetic dogs, with only limited success until finally dog No. 92, a yellow collie, jumped off the table after an injection and began to wag her tail. This discovery was short lived for Dr. Banting because his mentor and lab director, Dr. John J. R. Macleod, took over the research and eventually won the Nobel Prize in 1923. Dr. Banting refused to attend the ceremony, for although he shared the physiology prize with Dr. Macleod, he would not share a podium.

Consequently, the team was having difficulty making enough insulin for more than a handful of patients. This created a problem for a number of children “who had to wait while the Canadians fought bitterly with each other over how to fairly distribute their tiny amounts of the lifesaving substance.” Eventually, Eli J. Lilly and Company, the Indianapolis pharmaceutical firm, won the right to mass-produce insulin. “It was the first partnership negotiated among academia, individual physicians, and the pharmaceutical industry.” If it were not for this partnership and collaboration, where would medicine for diabetes be today? How many people would have suffered without this partnership?  

As Dr. Kent Sepkowitz, an infectious disease expert at Memorial Sloan-Kettering Cancer Center in New York pointed out, getting miracle drugs like insulin and the AIDS drugs to go from discovery to production is a “big challenge.” Nevertheless, pharmaceutical companies like Eli Lilly overcame such obstacles by playing an innovative role in helping cover the cost and logistics of large-scale insulin manufacture. Because of their work, by 1932, the price of insulin had fallen by 90 percent. That decline shows the true value of medicine pharmaceutical companies provide.

Today, according to the American Diabetes Association (ADA), 23.6 million children and adults in the United States—7.8% of the population—has diabetes. Of that amount, 17.9 million people are diagnosed, and 5.7 million people go undiagnosed. Additionally, 57 million people have pre-diabetes like factors, and each year, 1.6 million new cases of diabetes are diagnosed in people aged 20 years and older.

If it were not for this first partnership between academia, individual physicians, and the pharmaceutical industry, 8% of our population would still be suffering today. It then seems obvious that any one of those 23.6 million children or adults would tell those who criticize such collaboration that these partnerships and relationships are essential not only for their present health and well being, but for the future as well.

As a result, people must recognize the impact this partnership has had in the daily lives of millions of Americans and in numerous other diseases and conditions. Those with diabetes and other illnesses that have benefited from this partnership must speak up and show their support for this collaboration that has saved their lives in some case, and made them healthier in others. Otherwise, if we continue down a path that stifles these relationships and chills the willingness of researchers and physicians to collaborate with industry, we may never find the cures and treatments to diseases the way Dr. Banting did over eight decades ago.

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