Drug Innovation 8: Treating Men's Cancer

My elder brother died of prostate C a few years ago, then my mother's first cousin in Cebu. Nationwide, prostate C I think is among the killer diseases for men. My HMO or private health insurance told me once to undergo a test of prostate C as it might be hereditary in our family but I have done it yet. 

Today, there is a news report from interaksyon.com on men's cancer, that by 2027, the Cancer Research UK foresees that one-half of our gender worldwide will have one form of cancer developing in our body. Not a scary thought for me actually because I will be in the mid 60s by that time. But then any cancer cell can multiply anytime in one's body as one ages and as one's immune system gets weaker.

Here's portion of that news report:

LONDON - A man's lifetime risk of developing cancer is set to reach one in two by 2027, according to new figures released by the Cancer Research UK on Wednesday.

This prediction means that within 15 years 50 men out of every 100 are likely to be diagnosed with cancer at some point in their lifetime as opposed to 44 out of every 100 in 2010.

The research body predicted that women's lifetime cancer risk is also increasing and is predicted to rise from 40 to 44 out of every 100 women by 2027.

But it is still optimistic about cancer surviving thanks to better techniques.

"Cancer survival has doubled in the last 40 years thanks to research developing better techniques to detect the disease and improved treatments to increase survival," it said.

"So while the risk of being diagnosed with cancer is rising, the overall chance of surviving it is improving."

It held that age is the biggest risk factor for cancer and the increase in risk is largely due to more people living longer. As our lifespan increases more people will reach an age when they are more likely to be diagnosed with cancer....

Thanks to modern medicine and the life sciences. Human understanding of various diseases keeps improving. Understanding of a disease, how it starts and how it expands, is a prerequisite to developing a treatment, both in lifestyle change and in medication.

In an article this year in BusinessWorld, Medicines in Development for Cancer, Reiner Gloor of PHAP wrote,

Meanwhile, more than 30% of cancer could be prevented through healthy lifestyle, which includes non-tobacco use, a healthy diet, being physically active and moderate use of alcohol. Furthermore, the chances of beating cancer become higher each day with early detection, vaccination and a steady stream of innovative medicines.

The solid commitment to patients and the advancement of science are at the core of the sustained progress in the fight against cancer. Biopharmaceutical researchers are now developing 981 medicines for all cancer types. Many are high-tech weapons to fight the disease, while some involve innovative research into using existing medicines in new ways, announced the Pharmaceutical Research Manufacturers of America (PhRMA).

In its 2012 Report on Medicines in Development for Cancer, PhRMA revealed that several cutting-edge approaches are being employed in search for better treatments for cancer.

The report said that medicines in the pipeline include a drug that interferes with the metabolism of cancer cells by depriving them of the energy provided by glucose. Also in development is a medicine for acute myeloid leukemia (AML) that inhibits cancer cells with a mutation found in about a third of AML sufferers. The list likewise includes a therapy that uses nanotechnology to target the delivery of medicines to cancer cells, potentially overcoming some limitations of existing treatments, said the report.

In a bid to address major types of cancer, the report said that there are 121 medicines in development for lung, lymphoma (117), breast (111), colorectal (66), ovarian (63), and stomach (23) cancers among others. In addition, there are 94 medicines and vaccines in the pipeline for prostate cancer. Meanwhile, "orphan drugs" are being developed for rare cancer types that affect less than 200,000 people.

Researchers are also working on treatments for cancer types that affect children. There are medicines in development for brain cancer affecting the young for neuroblastoma, glioma, and glioblastoma.

Many of these candidate drugs have entered clinical trial, or the phase in research and development (R&D) that perform human testing involving up to 5,000 individuals to establish the safety and efficacy of the medicines.

Meanwhile, some medicines in development for leukemia have been granted fast track status or are considered orphan drugs.

Healthy lifestyle like avoiding excessive use of alcohol, tobacco, fatty food and drinks, having a more active rather than sedentary life, is still the best and cheapest defence in preventive healthcare. But should cancer cells or other diseases come in, the use of modern medicines should be tapped whenever possible. 

It is important that public policies and government regulations that tend to inhibit or discourage more medicine innovation, more innovative healthcare schemes under a competitive environment, should be avoided. There is money in healthcare, the same way that there is money in education and housing, in food manufacturing, hotels and restaurants, IT and telecomms, and there is even huge money in politics and excessive government spending. Different players in the pharmaceutical, biotechnology, molecular biology and other life sciences will come in when their risk-taking and health innovation will be properly rewarded, not demonized by politics and heavy government regulations like IPR busting and price control.

Drug Innovation 4: New Anti-Cancer Drugs

A good article today in BusinessWorld by Reiner Gloor of PHAP, about several hundred new medicines being developed, many of which are still in the laboratories and undergoing various clinical trials, against various types of cancer.

Good healthcare is mainly about having healthy lifestyle, avoiding high intake of risky substances like tobacco and alcohol products, high fat/high calorie food and drinks, early detection of diseases for early and less costly treatment, and new, more powerful medicines against diseases once the latter have developed inside our body.  The production and sale of generic drugs once the patent on innovator drugs have expired, is also an important part of good healthcare.

I also included his paper last year also from BWorld, about the discovery of Insulin. Below, photos of various cancer cells, from top left, clockwise: (a) breast cancer, (b) brain cancer, (c) prostate cancer, (d) a cancer cell being attacked by the immune system, (e) lung tumor, (f) brain cancer.

Photo sources:
1. http://www.alternative-cancer.net/Cell_photos.htm
2. http://www.environmentalgraffiti.com/featured/images-inside-human-body-images/8292
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(1) Medicines in development for cancer

Medicine Cabinet -- Reiner W. Gloor
June 08, 2012

http://www.bworldonline.com/weekender/content.php?id=53071

Some do not want to talk about it while others call it the Big C. Experts refer to it as an emerging epidemic as well as a leading threat to global health and development. Whatever it may be called, cancer is no matter to be taken lightly.

Around the world, fathers, mothers, sons, daughters, and friends have lost loved ones to cancer. Men and women, adult and children, and rich and poor alike, are all vulnerable to the disease that has developed into one of the world’s biggest killers.

Cancer, along with cardiovascular diseases, diabetes, and chronic respiratory diseases altogether prematurely claimed the lives of 38 million people in 2008, affecting the developing world and lower-income populations hardest. In fact, about 70% of cancer deaths occurred in these countries where health systems are characterized by high out-of-pocket spending.

In the same year, the World Health Organization (WHO) said that 7.6 million died of cancer, representing around 13% of deaths worldwide. In the Philippines, the GLOBOCAN Project reported that there had been more than 51,000 cancer deaths in the country in 2010.

The GLOBOCAN Project, a WHO initiative provides global incidence of mortality and prevalence from major types of cancer, reported that leading cancer deaths among Filipinos in 2010 include those involving the lung, liver, breast, colon/rectum, leukemia, stomach, cervix, uteri, brain, prostate and pharynx.

There are valid and serious reasons why people fear cancer. For one, there are more than 100 types of cancer that could affect just any part of the body. And, as mentioned, it defies gender, age and socio-economic class. If not detected early on, worldwide statistics would attest to its irreversible consequences. The WHO disclosed that deaths from cancer worldwide are projected to continue rising, with an estimated 13.1 million deaths in 2030.

Meanwhile, more than 30% of cancer could be prevented through healthy lifestyle, which includes non-tobacco use, a healthy diet, being physically active and moderate use of alcohol. Furthermore, the chances of beating cancer become higher each day with early detection, vaccination and a steady stream of innovative medicines.

The solid commitment to patients and the advancement of science are at the core of the sustained progress in the fight against cancer. Biopharmaceutical researchers are now developing 981 medicines for all cancer types. Many are high-tech weapons to fight the disease, while some involve innovative research into using existing medicines in new ways, announced the Pharmaceutical Research Manufacturers of America (PhRMA).

In its 2012 Report on Medicines in Development for Cancer, PhRMA revealed that several cutting-edge approaches are being employed in search for better treatments for cancer.

Drug Innovation 2: Sustaining Innovation via Competition

I noticed today on twitter a number of messages on the annual meeting of the Pharmaceutical Research and Manufacturers of America (PhRMA) Annual Meeting in Boston, so I checked their website, http://phrma.org/.

Saw this photo there, good theme. Medicines, whether innovator or generics, so long as they are the real ones (ie, non-fake, non-substandard) and have passed stringent requirements for safety and efficacy by the drug regulatory agencies, and are regularly monitored via pharmaco-vigilance, should be useful to people and communities.

There should be no debate on the delineation of service and usefulness between innovator drugs and generic drugs because most, if not all, generic manufacturers recognize the high risks and huge costs of inventing new medicines against various diseases -- old, emerging, mutating/evolving new ones. Thus, intellectual property rights (IPR) schemes like patents are generally recognized.

But there are certain sectors and ideological interests, political groups and politician interests, that do not want to respect IPR schemes by which innovator companies abide by existing rules. And various debates and new government regulations that tend to demonize innovator companies while silently praising their newly invented drugs have cropped up.

I believe that patients and public interest will be maximized if we have more, not less, innovator companies around, competing with each other in giving us more powerful treatment and medications. After their new drugs' patent have expired, a new round of competition, more fierce competition in fact, comes in with the entry of many generic manufacturers. And public interest is further advanced with more choices, more options for patients and health professionals.

Anyway, I am posting below four short articles from the PhRMA website that are related to medicine innovation and their Boston meeting, below. Enjoy.
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Opportunities Abound, Say Viehbacher and Lechleiter

by Kate Connors on 4/13/2012

In their moderated discussion this morning, outgoing PhRMA Chairman Christopher Viehbacher (from Sanofi) and incoming PhRMA Chairman John Lechleiter (from Eli Lilly and Company) discussed ways that companies can maximize different types of opportunities.

Of course, in the biopharmaceutical sector, science is key. As Viechbacher said, the promise of the research happening now is built on knowledge we’ve developed in the past: “Most of our success in the 1990s was based on targets that came out of research in the1970s and 1980s. Now we’ve got new targets coming out of NIH and it’s opening up opportunities everywhere. If we can come up with new models, we can capitalize on these opportunities.”

Lechleiter concurred: “There’s a sense in the room today of much more optimism than pessimism. People critical of how much R&D we’ve spent in a last decade with what they call diminished returns are looking in the rear-view mirror. I’m encouraged by the way that large companies, small companies, government and academia can work together.”

He also highlighted the President’s Council of Advisors on Science and Technology, which is working with many PhRMA members as well as other stakeholders, as an opportunity to improve the way that we get medicines to patients.

Both agreed that increased collaboration with patients can also help open doors to both research and access, as well.

As Viehbacher said generally, but significantly: “There are enough opportunities to go around.”

Inspiration for Advancing Medical Innovation

by Christian Clymer on 4/13/2012

This is a guest post from John C. Lechleiter, PhD, who is Chairman, President and CEO of Eli Lilly and Company. Starting today, Mr. Lechleiter is also the Chairman of the Board of Directors of PhRMA.

The biopharmaceutical industry is all about medical innovation. It’s our lifeblood. Yet, too often we talk about medical innovation without making it hit home for people outside the industry.

Rewind to three decades ago, when HIV first became a major public health concern. Not only were we on the verge of a human disaster, but public health officials worried that we wouldn’t have enough hospitals to treat an approaching avalanche of AIDS patients. Thanks to medical innovation, it didn’t happen (AIDS deaths have dropped by 70 percent since 1995). Similarly, thanks to a two-thirds drop in the death rate from coronary heart disease in the U.S. since the 1960s, 1 million more Americans are alive each year. Anti-hypertensive treatments alone account for 800,000 fewer hospitalizations each year – and 86,000 fewer deaths.

These are impressive and important success stories, but our work is far from over. Fast-forward to today: too many people still die from cancer. Diabetes is growing at epidemic rates. And Alzheimer’s disease represents an imminent crisis. The Alzheimer’s Association says that by 2050, more than 13 million Americans will have the disease – at a cost of more than $1 trillion annually – unless better treatments are found.

Sustaining our advances in medical innovation is priority one -- and it’s incumbent upon all those in our industry to make it happen. The ongoing revolution in the life sciences, with all its promise, will mean little without public policies that foster innovation. We have to get our story out in compelling and meaningful ways. Our industry must also continue to build trust with our various stakeholders. By telling the stories of our mothers and brothers and children who’ve been saved by new medical treatments – and by upholding the highest standards of integrity and ethical behavior in everything we do – the fruits of our efforts can be fully realized.

I’m proud to chair PhRMA’s board for the next 12 months – and it’s an honor to be part of an industry that focuses on saving lives. But let’s not look at our past successes as some sort of historical footnote. Let’s use them as inspiration to find new innovative treatments for the next generation of patients. They’re waiting.

What April 12 Means to PhRMA’s Chairman

by Kate Connors on 4/13/2012

New PhRMA Chairman John Lechleiter, President and CEO of Eli Lilly and Company, continued the vein of optimism in his comments this morning. He urged those of us in the room “to stand up for policies that support innovation, to continue to build trust with our stakeholders, and to get our powerful story out.”

We must do so, he said, to continue the “heroic work of healing and saving lives well into the future.”

Yesterday’s date, April 12, is “famous in the annals of innovation.” On that date in 1961, the first human flew in space. Twenty years later to the date was the launch of the space shuttle program. Around the world, these moments in space exploration have been held up as examples of true innovation.

However, Lechleiter said, there is a much more important April 12. On that date in 1955, it was announced that Jonas Salk’s polio vaccine worked: “That vaccine turned a disease that once horrified America into a memory, and over time would do so for most of the world.”

He added: “Medical innovation over the past century transformed the basic expectations of human life that had prevailed since the dawn of civilization.”

Lechleiter continued, discussing the overall value of prescription medicines. And he discussed medical need. And he discussed increases in generic utilization rates.

But after the last day and a half of conversation about innovation, collaboration and development, it feels good to focus on the aspirational, because all of us here in Boston certainly share that optimism: “I believe that the juxtaposition of new insights into human biology, coupled with the application of new tools and advancements in technology, has the potential to revolutionize our business more in the next ten years than in the past 50.”

He closed urging us all to “preserve the innovation that is at the heart of what we do and that people are counting on us for.”

PhRMA Member Companies Invested $49.5 Billion In Research and Development in 2011

2012 Industry Profile and Updated Chart Pack Resource Now Available

Washington, D.C. (April 12, 2012) — Investment in research and development by members of the Pharmaceutical Research and Manufacturers of America remained strong at $49.5 billion in 2011, as the sector adapts to meet the challenges of evolving science, a changing marketplace and a difficult economic environment.

Biopharmaceutical research companies are continuing to explore the possibilities associated with more targeted therapies and personalized medicines, and are building on the benefits associated with partnerships among experts throughout the research ecosystem.

These efforts are reflected in PhRMA’s new 2012 Industry Profile as well as an updated version of its informational chart pack resource, “Biopharmaceuticals in Perspective,” both released today. Both sets of materials are available for public use and are intended to provide  timely, relevant information about the biopharmaceutical research sector, which includes both pharmaceutical and biotechnology companies.

The 2011 R&D investment figures reflect the biopharmaceutical sector’s standing as America’s most research-intensive industry. According to a recent report by the National Science Board of the National Science Foundation, the U.S. biopharmaceutical sector accounts for the single largest share of all U.S. business R&D, representing nearly 20 percent of all domestic R&D funded by U.S. businesses. In the U.S., R&D expenditures among PhRMA members represented a remarkable 21.1 percent of domestic sales....
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See also:
Drug Innovation 1: On Cancer, Bioequivalence and Clinical Trials, March 28, 2012
IPR and Medicines 16: Wikileaks and the Cheaper Medicines Law, November 08, 2011

IPR and Medicines 17: Why are Drugs Still Expensive After Patents have Expired? November 17, 2011

IPR and Medicines 23: Profitability of Innovator Pharma Companies, March 16, 2012
IPR and Medicines 24: Balancing Costly Innovation and Cheaper Drugs, March 20, 2012

Drug price control 1: IPR and taxes on medicines

(Note: the original title of this paper was 'IPR, drug price control and taxes". I retitled it to reflect a discussion series on the subject starting in January 2011)

It is drug price control and taxes, not piracy and intellectual property rights (IPR) violation so far, that hound the Philippine pharmaceutical market. Not only innovator companies but also local generic manufacturers were adversely affected by the continuing government drug price regulation policy.

In a headline news story in BusinessWorld last January 4, 2010, RP anti-piracy ‘strides’ cited, it said,

A WASHINGTON-based group of drug firms has retracted its earlier petition to the United States government that the Philippines be placed on the priority watch list of countries notorious for intellectual property (IP) violations.

The Pharmaceutical Research and Manufacturers of America (PhRMA) has instead recommended that the Philippines be merely retained in the regular watch list, after observing "notable strides" in the government’s willingness to hear out the private sector...

While challenges remain, the Philippine Government has made notable strides in engaging with the research-based pharmaceutical industry on critical intellectual property and market access issues," PhRMA said in a document dated Dec. 10…

PhRMA also took issue with the Maximum Drug Retail Price Mechanism which was authorized by the law, saying the scheme "has recently impacted [sic] a number of PhRMA member companies’ access to the Philippine market.

The Philippine government, through the Cheaper Medicines Law or RA 9502, wanted to bring down medicine prices by tinkering with IPR laws like drug patents which the government issued in the first place, and by drug price control. Issuance of compulsory license (CL) via local manufacturing by non-innovator companies of still patented drugs, or via parallel importation, are the most prominent provisions of the law.

The more than 20 years of generics promotion by the Department of Health (DOH) through the Generics Act of 1988 has improved competition among innovator multinationals and generic local manufacturers. There were already cheaper generic alternatives even for the most popular and patented drugs by the multinational pharma companies.

The most prominent example is amlodipine (anti-hypertension). When the DOH implemented the 50 percent mandatory price cut policy in 2009, the poor found the new price of P22.85 Norvasc 5mg tablet still expensive. So the poor continued patronizing the P8.50 generic alternative. Picture here are prices by one branch of The Generics Pharmacy sometime last year. Click on the picture to see a larger image.

The policy’s goal of making popular drugs more affordable to the poor was not attained.

The rich and middle class who used to patronize Norvasc at close to P46 a tablet greatly benefited as they shelled out only half that value after the price control policy. Local generic manufacturers who were selling their drugs at P18 to P25 were forced to further bring down their already lower prices as the price of the leading drug was forcibly brought down by the government to only P22.85.

I saw this in one generic drugstore in one Uniwide mall, prices as of end-December 2010. Amlodipine 5mg was selling as low as P5.50 with equivalent ("katumbas ng") curative capacity of Norvasc. Atorvastatine (anti-cholesterol) 10 mg tablet, a generic was selling at only P20.50 while the innovator drug, lipitor, also made by Pfizer, is sold at P34.45, from its original price of almost P69 10mg tablet.

If competition among different drugs is working, what does the government care if one multinational company will sell its drug at P100 or P200 per tablet when the public has access to local generic drugs selling at only P10 or P5? Let the former overprice its product, lose its buyers, and commit business suicide.

The bigger challenge for government remains undone until now. Government should drastically cut, if not abolish, its taxes on drugs and vaccines, to make them cheaper and more affordable to the poor. The 5 percent import tax and 12 VAT on drugs contribute to at least 17 percent “more expensive” medicines. For instance, an imported medicine with a landed price of P20 per tablet, after the import tax and VAT have been applied, will immediately have a pre-retail price of P23.52 per tablet. Government is responsible for P3.52 price increase via taxes alone.

The lessons for all these are simple: One, competition is kicking hard among many drug products and drug producers, and government price control policy is distorting this dynamic competition. And two, government should instead look inward and drastically cut or abolish its taxes on medicines, to contribute to its avowed goal of “cheaper medicines for the poor.”