Medicine for Big Pharma's Anemic Condition

The Journal accurately describes the drug industry's malaise ("Big Pharma Faces Grim Prognosis," page one, Dec. 6), but it isn't so much that "the industry's science engine has stalled" but that government regulators have slammed on the brakes. Over the past decade or so the Food and Drug Administration has become more progressively risk-averse and defensive in its decision-making. Regulators have been encouraged to promote greater drug safety but seldom have been called to account for the unnecessary suffering and deaths of patients who don't get the new drugs they need in a timely way.

This asymmetry will be further worsened by amendments to the Food, Drug and Cosmetic Act that President Bush signed in September. The bill raises the punitive tax, or "user fees," on drug companies and provides regulators with additional sticks with which to flog drug developers in the guise of enhancing "drug safety." What we need are strategies to make regulators more efficient, effective and smart.

The FDA keeps raising the bar for approval, especially for innovative, high-tech products. Moving the goal posts in the middle of the game -- such as increasing the number of patients who must be tested before approval -- is particularly vexing for drug developers. In addition, a number of medicines previously granted marketing approval in Europe have received "approvable," instead of approval, letters from the FDA, meaning that additional data is required before the drug can be marketed.

As to the statement by the FDA's spokesman that "The threshold for what we consider to be a safe, effective drug hasn't changed," he needs a whopping dose of something that will improve his reality testing.

Henry I. Miller, M.D.
The Hoover Institution
Stanford, Calif.

(Dr. Miller was an official at the FDA from 1979 to 1994.)

Frankly, I am tired of hearing Big Pharma complain. There may be a crisis looming, but it is largely a self-made crisis and not even close to the one faced by patients who haven't been able to afford their medicines in recent years. Big Pharma has consistently outperformed many Fortune 500 companies in profitability, a cost largely shouldered by the health-care consumer and U.S. taxpayer. The top-tier companies, while commanding about two-thirds of the market, have produced the minority of innovative drugs in the past decade. The brunt of their FDA applications and approvals have been for "me too" drugs. Furthermore, they have successfully avoided expiration of their patents by what could best be described as legal tricks. Yes, their R&D costs have risen and drug trials now have to be larger, but their marketing budgets have risen even more. Cutting back on consumer advertising as well as payments and "gifts" to physicians would free up billions of dollars. Putting that toward lowering drug costs and investing in R&D will produce results for patients and likely for shareholders, too.

Benjamin Schaefer, M.D.
Bangor, Maine

As a former salesman for GlaxoSmithKline, I can tell you that the prognosis has been grim for several years. The primary method of drug development was based on finding receptors that created responses, and those receptors were discovered years ago. Check the recent new drug applications filed with the FDA. Many have XL, XR, CD or some other nomenclature that implies a slight change in the molecule, or else it's a combination of two already-existing products.

The future lies with the biotech industry, but it will create a different pharmaceutical marketplace. As biotech makes further advances, it will work on narrower niches. The days of blockbusters like Lipitor are over since biotech suggests a more targeted and narrower approach. The main difference will be seen in the size of pharmaceutical sales forces. They will get smaller, and that is already happening. That sound you hear is the sigh of relief from America's physicians.

Source:online.wsj.com

Hospira to market first biogeneric medicine

Lake Forest-based hospital products maker Hospira Inc. said today it landed European authorization to market the biogeneric anemia drug Retacrit in Europe, making the medicine its first marketed biogeneric medicine.

Hospira said it will launch the product, used to treat anemia in cancer and dialysis patients, in Europe beginning with Germany in early 2008, but Hospira executives said earlier that the drug won’t have an impact on Hospira’s bottom line in the next few years.

Biogenerics or biosimilars are cheaper generic versions of expensive biotechnology drugs, which are made from genetically modified living cells. Patients and their health insurers face annual drug costs of $20,000 to $200,000 for some of the high-tech life-saving biotechnology medicines, with which biogenerics would compete.

Unlike in Europe, there is no legal pathway in the United States at present to bring to market biogenerics. But Hospira is among companies pushing Congress to change that.

Retacrit will compete with the branded biotechnology drug Epogen, sold by Amgen Inc. and Johnson & Johnson and part of a $2 billion branded market in Europe.

“We are proud to offer Retacrit to patients and healthcare professionals in Europe, because it will lead the way in establishing a well tolerated and effective anemia treatment with significant cost savings,” said Michael Kotsanis, Hospira’s president of Europe, Middle East and Africa.

Hospira spokesman Jason Hodges declined to specify the price the company will set for Retacrit, saying it’s premature.

Retacrit is manufactured and packaged in Europe. It is being developed, manufactured and distributed under agreements between Hospira and Germany-based Stada Arzneimittel AG and Bioceuticals Arzneimittel AG.

Source:www.suntimes.com

Falling Into a Medical Abyss

Some days I wish I had cancer. I'm even tempted to tell casual acquaintances that I have cancer, because when I say "severe aplastic anemia" they look at me blankly, or they reply that their aunt Sheila has anemia or, worse, they say, "Thank God you don't have cancer." That's what the hematologist said after reviewing my bone-marrow biopsy: "The good news is, you don't have leukemia."

I run my uncle's internal-medicine practice, so I see cancer patients and survivors all the time. There isn't much that shocks or frightens anymore in this exhibitionist age, but there's one bridge that everyone still trembles before: cancer.

Yet during my first trip to the oncology ward—oncology because there are no wards for aplastic anemia—four successive roommates, all leukemia patients, returned to their lives after receiving treatment while I stayed and reflected on mine.

Aplastic anemia is a noncontagious disease in which, for unknown reasons, the body's immune system destroys newly formed blood cells in the bone marrow, causing life-threatening anemia and high risk of infection and hemorrhage. When you have a rare disease like mine, you don't fall through the cracks in the system—you fall through a gaping abyss. There is no money for what you have, no telethons, no support groups, no ribbons of camaraderie. Because there is no profit in developing and testing drugs for rare diseases, they've been lumped together as "orphan" maladies, much as real orphans are crowded together in one place to be more efficiently cared for. And the metaphor of being an orphan feels all too real, as if you're abandoned to dark corridors while mansions are constructed to treat diabetes and AIDS and Alzheimer's. When you're an orphan you envy people with families, even such horrific families as cancer.

Source:www.newsweek.com

Postpartum Anemia

As we head into 2008 it’s time to get your health in check. If you are low on energy or feel overly tired or weak—you could be suffering from iron deficiency anemia—especially if you are a new mom.

As many as one in five women will suffer from excessive blood loss during their reproductive years. This causes a condition called anemia, which can have debilitating physical and emotional effects. Of the approximately 4 million women who give birth each year, about 2 million become iron deficient, and more than 1 million will suffer from postpartum anemia

“Postpartum anemia not only affects maternal mood, thinking and behavior – but can also have adverse effects on the baby and has been shown to cause developmental delay, said Dr. Mary Jane Minkin, clinical professor of Obstetrics and Gynecology in the Department of Obstetrics and Gynecology at Yale University School of Medicine and author of A Women’s Guide to Sexual Health.

Infants of mothers who are anemic at 10 weeks postpartum have been shown to experience developmental delay; moreover, these early deficits in infants may not be reversible by subsequent successful treatment of the mother’s anemia.

Source:www.healthnewsdigest.com