IPR and innovation 40, WHO health alarmism and IPR tinkering

Seven years ago, I briefly surveyed the various offices under the UN and I was surprised to see about 100+ different agencies. See UN bureaucracies -- too many! (December 20, 2010).

Among the huge and wide UN offices and bureaucracies is the World Health Organization (WHO). On its website, Media Center, News Releases 2017, these stories seem like we are still in the 90s or even the 80s, or the 70s -- there are many scary and alarmist stories in public health around the world until now.

It is already 2018 -- when illiteracy is already zero in many developing countries, when smoke signal and animal whistles are no longer used to communicate as hundreds of millions of poor people in developing and emerging countries now use smart phones with access to emails, facebook, twitter, youtube and other social media.

And the WHO and WB still declare that "half the world lack access to essential health services"? That measles "still kills 90,000 per year"?

Going back a few decades ago, the WHO was known for various health alarmism worldwide. Like the HIV/AIDS alarmism in the 80s to 90s and more recently, about NCDs (non-communicable diseases) alarmism.

Then the usual fare of the WHO -- blame directly or indirectly IPR and drug patents by innovator pharma and biotech R&D. Also blame free trade and FTAs for expensive medicines.

And I was surprised to see this.

http://www.who.int/medicines/EB142_13_shortage_and_access_medicines_vaccines.pdf?ua=1

"Global shortage of medicines and vaccines", wow. Since about 95-99% of WHO's essential medicines list (EML) are already off-patent, what stops the WHO and member-governments from mass-producing these drugs, directly or indirectly?

The WHO needs to shrink, both in size of bureaucracy and governments' funding. It has lots of health and economic global central planners that they want to plan-and-control many things and policies, forgetting that it was the private sectors and corporations' risk-taking that gave the world plenty of life-saving medicines since many decades ago.
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See also:

IPR and innovation 37, US-China dispute on IP, September 17, 2017

IPR and Innovation 38, Recent IP development in some ASEAN countries, October 24, 2017 

IPR and Innovation 39, Recent IP developments in CN, TW, KR, ID, November 05, 2017 

My first article in BWorld, Oct 2007, on IPR, December 29, 2017

UHC 26: Public and Private Spending on Health

The 3rd paper which I briefly discussed in Ateneo last Wednesday night was about healthcare spending. Some data here I belatedly added as I ran out of time preparing three different topics in one lecture.

I also used some old data, 2011, 2007, but current numbers should not be too different.

A time series data on number of physicians over 22 years in selected Asian countries.

Many people say that government spending in healthcare is "not enough". Really? These national and local agencies are not small. Public spending in healthcare is big. What makes them "small" perhaps is the huge amount of wastes and leakage. Like spending more money on salaries and perks of government personnel and officials who are not providing relevant or useful service delivery.

Universal healthcare (UHC) in the Philippines.

An example of wastes and leakage in the government health delivery system.

Private spending in health, at least in the corporate and pharma sector.

Average life expectancy of people anywhere in the planet is rising. Many people do not recognize this and only point out the pessimistic and negative scenario.

I made the following concluding notes.

* Reduce taxes on medicines and healthcare. import tax 1-5% + VAT 12% + local government taxes.

* Encourage, invite more players in pharma (innovators and generics), drugstores, hospitals. Competition from more players is often the best insurance to bring down prices and improve products and  services quality.

* Focus on fighting substandard, fake medicines, in partnership with civil society. Protect the public via quality control, not drug price control,

* Do not re-centralize healtcare, allow decentralization and competition among LGUs, among private health  insurance, drugstores, hospitals, pharma.

The 15-slides presentation is available in  my slideshare account.
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See also: 

UHC 22: Shortage of Doctors in the Philippines, February 10, 2014 

UHC 23: Orthopedic Hospital Corporatization, Not Privatization, February 21, 2014 

UHC 24: Corruption in Government Purchase of Medicines, April 02, 2014 

UHC 25: Some Physician Stories in Hospital ERs, Wards, July 29, 2014 

IPR and Medicines 31: The Policy Workshop's Hong Kong Dialogue, November 28,  2014

IPR and Medicines 32: The Policy Workshop's Hong Kong Dialogue

It was another stimulating discussion on "Policy Dialogue on IPR and Innovation", a small group forum for independent and market-oriented Asian think tanks held in Harbour Grand Hong Kong last November 5, 2014 and sponsored by The Policy Workshop (TPW), a NY-based public affairs firm.

The  night before the Policy Dialogue and after the Lion Rock Institute's Reading Club Salon 2014, TPW sponsored a dinner at the hotel. Our group photo below, a mixture of Reading Salon + Policy Dialogue participants.

The small group  forum was under the Chatham House Rule, we participants can mention the subjects and ideas discussed but not the persons who said them. It is a cool way to encourage honest, no holds-barred expression of opinions, observations and  data.

Here are two of the various slides presented that day. It shows that despite all those talks of "worsening inequality", "the poor getting poorer", "diseases destroying humanity", and thus, "governments should intervene more, centralize healthcare more", the facts say otherwise. We are living healthier, more disease-free, have longer lifespan, than our predecessors a century or many decades ago. 

Related chart, declining death from infectious diseases and rising life span worldwide, 1900 to around 2013. Data from the Hamilton Project.

Among the main reasons for the huge decline in mortality was the control and effective treatment of infectious or communicable diseases, thanks to drugs and vaccines innovation. What used to be killer diseases have become preventable, and so people's lifespan has significantly increased.

Drugs and vaccines innovation, competition among innovator companies, plus follow up competition from generic companies for off-patent drugs and vaccines, and not more government politics or price control, are the significant drivers for revolution in healthcare and declining mortality.

 The Human Genome Project (1990-2003) is a successful, innovation-led project. Lots of jobs created, direct and indirect to biopharma sector, and billions of dollars of revenues for the companies and researchers involved, savings in public health spending. When people live longer and healthier, then they can work longer and more productively. 

Ahhh, cancer. My elder brother died of prostate cancer. My sister in law, his wife, died earlier of pancreatic cancer. Two of our wedding godmothers have died  of cancer too. It is among the higher killers in modern society. But I notice that recently, average survival rate of cancer patients is slowly rising. As modern science understand the various types of cancer better, various types of treatment and new medicines can be developed.

New medicines are being developed and invented against cancer alone. There should be hundreds of thousands of molecules that were tried, only 900+ showed some promises and not all of them will become successful and commerciable. Some if not many of them may fail in the final stage of clinical trials. But these innovations

Expensive medicines at the start, those newly-discovered or newly-invented molecules, are to be expected. Why? Because R&D, the long process of clinical trials involving thousands of people, is very costly. It is not cheap as some anti-IPR activists would  argue. If they are right, then  many of those big and medium-size generic firms should be doing drug invention and innovation as well but they are not.

This slide attracted some comments from some of us participants in  the dialogue. The anti-IPR activists can argue that IPR protection benefits mainly the US-based biopharma companies.

One participant answered it, the  critique is true because many US companies started it and continue to invest heavily in this high risk, high returns/high failure endeavor, and that explains the gap between the US and Europe, Japan, other countries. 

I think that instead of criticizing or  demonizing the US-based biopharma companies, the critics should ask why there is not much innovation in Europe, Japan, etc. in biopharma sector. No one is prevented from putting up a high tech research company, no one is prevented from networking and collaborating with university research centers. 

Ok, this is among my favorite photos that dinner before the dialogue. Six men from five countries (me from the PH, Wan from Malaysia, Choi from S, Korea, Barun from India, Mao and Feng from China) and Cathy Windels, the President of TPW. The six of us are among the regular or annual invitees of the EFN and we all participated in the Policy Dialogue. Cathy has worked with some of us since a decade or more, like Barun. I first met Cathy in 2007 also in HK through the International Policy Network (IPN) and then IPN President Julian Morris. Thanks Julian.

Thanks again Cathy and TPW for such a wonderful and stimulating discussion. Lots of useful data, lots of insightful comments.
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See also:
IPR and Medicines 28: Politicizing Innovation, Rewarding Rent-Seeking, April 06, 2013
IPR and Medicines 29: Parallel Importation and Patent Linkage, August 19, 2014
IPR and Medicines 30: R&D and Innovator Companies, November 03, 2014 
IPR and Medicines 31: Trademark Stealing and Counterfeit Medicines, November 17, 2014

On IPR Abolition 18: Patent, Copyright and Jeffrey Tucker, May 15, 2013

IPR and Innovation 19: The Policy Workshop Seminar in Hong Kong, October 21, 2014

IPR and Medicines 30: R&D and Innovator Companies

Interesting  data here. Out of the top 10 biggest firms in the world in terms of R&D spending, five are pharma (Roche, Novartis, Merck, Pfizer, J&J), three are IT (Samsung, Intel, Microsoft), and two are automobile firms ((Volkswagen, Toyota). Latest data March 2014. 

Source: Raconteur, Intellectual Property 2014

But in terms of top 10 firms in terms of number of patents held, zero from pharma, almost all of them are IT companies.

From this article:

"It’s estimated that currently up to 80 per cent of stock market values are based on intangible assets. This compares to just 20 per cent in 1975, the year before Apple was founded. This remarkable difference reflects the fact that many companies in 2014 operate in industries with very little machinery or other fixed assets. Accordingly the observed company value must be attributed to intellectual assets such as brand value and other IP...

"The importance of IP is particularly apparent in the pharmaceutical sector, where the expiry of dozens of critical patents has wiped billions from the value of the industry over the past few years.

"On March 12 for example, Pfizer’s stock was suspended for 20 minutes on news that its blockbuster pain drug Celebrex would lose its patent protection 18 months earlier than expected. Pfizer stock closed down almost 3 per cent, a meaningful number for a company with almost $200 billion in market value...."

Yes, people simply want to live long -- against cancer (there are about 200+ different types of cancer), against Alzheimers, against various infectious diseases (dengue, malaria, HIV, MERS-CoV, ebola, etc.). There are ethical and economic issues, some people think the cost of R&D by innovator pharma should be neglected, the fruits of their successful drug inventions should be shared to all. This is a wrong argument.

More interesting infographics here, http://raconteur.net/.../ranking-the-worlds-most...

10 Most innovative nations in the world, 2014 (Raconteur)

1. S. Korea (and #3 by R&D intensity, #2 by patent activity)

2. Sweden (#4 by R&D intensity)

3. US (#10 by R&D intensity, #5 by patent activity)

4. Japan (#5 by R&D intensity, #3 by patent activity)

5. Germany (#9 by R&D intensity, #6 by patent)

6. Denmark (#6 by R&D intensity)

7. Singapore

8. Switzerland (#8 by R&D intensity)

9. Finland (#2 by R&D intensity)

10. Taiwan (#7 by R&D intensity, #1 by patent)

That's 4 from Asia, 5 from Europe and 1 from N. America..

Israel is #1 by R&D intensity, China is #4 by patent; both though are not in the top 20 most innovative nations in the world.

Samsung spent big time money in R&D because it wanted to topple Motorola, Nokia, other previous heavyweights in mobile phone and electronics. The innovator pharma spent big time money on R&D because the demand by patients, rich and poor, for new, more revolutionary, more disease-killing medicines, is high.

If governments are involved in many countries in pharma, it is more of helping the generic manufacturers, not the innovators. See policies like drug price control, compulsory licensing (CL), special CL, etc. All these are aimed and targeted at innovator pharma, never at generic pharma.

In the case of medicine innovation by innovator pharma, all of their new medicines that start out as patented, more expensive drugs "for the rich" for about 8-10 years (the various regulatory approvals, multiple clinical trials, take about 10-12 years out of total patent life of 20 years) ultimately become off-patent, the generic manufacturers come in and multiply the production at cheaper price, benefiting the poor. Government has zero role here except as drug regulatory agency via FDA and still the poor will benefit.

Here's a good chart. It shows that out of the 20 years patent life of a newly-invented medicine, up to 13 years are gobbled by R&D, pre-clinical, clinical trials, registration. Each stage must get regulatory approvals from government FDAs.

Source: IFPMA, 2012. The New Frontiers of Biopharmaceutical Innovation.

Exploratory stage: 2 to 4 years identifying antigens to prevent or treat a disease. Selected candidate vaccines will continue the process.

Pre-clinical stage: 1 to 2 years assessing antigens’ safety in animals and selecting the best candidate vaccine to continue the process.

Clinical development: 6 to 7 years Testing the candidate vaccine in humans.

Phase I: test of safety on 10 to 100 volunteers.

Phase II: Evaluation of the immune response in 100 to 3,000 volunteers.

Phase III: Large-scale tests of the vaccine’s efficacy and tolerance on 3,000 to 40,000 volunteers.

Registration: Synthesis stage from 12 to 18 months

Another good chart, the vaccine development cycle. Same source above, IFPMA.

Innovation and IPRs like patent, copyright, trademark, should be protected. Not all ideas are the same. Stupid ideas are numerous and endless, readily available anywhere, they do not need protection. Bright ideas are scarce, they need protection.

Governments should fully appreciate and recognize this, and not be easily pressured by populist demands to confiscate or disregard IPRs and give to some (very likely, crony) local firms.
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See also:
IPR and Medicines 26: Novartis' Glivec and India's IPR Ruling, April 01, 2013, 
IPR and Medicines 27: More on Glivec and India's SC Decision, April 02, 2013
IPR and Medicines 28: Politicizing Innovation, Rewarding Rent-Seeking, April 06, 2013
IPR and Medicines 29: Parallel Importation and Patent Linkage, August 19, 2014

Drug Innovation 13: Why Expensive Cancer Drugs Are Cost-Saving After All

When I read this article, I thought this is like a home run hit, all three bases covered and back to the home base. Well written, data well-provided, and arguments well-organized. A heretic but truthful argument. Published in Forbes.com last Monday, June 10. Enjoy.
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Why We Should be Spending More on Pricey Cancer Drugs

By Scott Gottlieb, M.D.

Here’s a heretical statement: We don’t spend enough on high-priced cancer drugs.

In recent months, there have been provocative editorials by leading academic cancer doctorsarguing that the price of many new cancer drugs is too high.

But what if the high price of new drugs is a reflection of the value that these medicines bring to not only individual patients, but also our healthcare system?

Doctors can reject the early data available at the time of initial FDA approval of a particular drug. They can rightly use their discretion to prescribe an older, cheaper medicine over a costlier alternative that hasn’t decisively proven is superiority.

But it’s harder to argue that we’re not getting real, overall progress for the price we’re paying. Not only in terms of better clinical outcomes, but cheaper care, as expensive drugs reduce the need for even costlier hospitalizations.

Although very costly, total spending on oncology care (as a percentage of our $2.7 trillion national healthcare budget) has been remarkably constant over the last 20 years, at just less than 5% of total healthcare spending (and about .8% of U.S. GDP).

But the mix of expenditure has changed dramatically over time. Far less money is being spent on services like hospitalizations, and far more on outpatient medicines.

Cancer treatments that used to make patients very sick and require costly hospitalizations have been replaced with targeted drugs that can allow patients to be more easily treated at home. Part of the shift to outpatient treatment was driven by economic incentives that made it more profitable to prescribe cancer drugs in doctors’ offices. But this shift was also driven by the wider use of less toxic, more effective medicines that could be safely administered in doctors’ offices.

The proportion of spending on inpatient cancer admissions fell from 64% of total cancer spending in 1987 to 27% in 2001-2005 according to studies. A good review of this data can be found in ananalysis published in the journal Oncology.

Here’s what’s happened: The transfer of cancer care to the outpatient setting has produced substantial savings. It’s cheaper to deliver care outside the hospital, in doctor offices. This is certainly true for inpatient care. It also applies to outpatient care delivered in hospital-based clinics. One study by Avalere Health that examined three years of health claims data found (after adjusting for other variables) that the average cost of an office-based episode of cancer care was about $28,000 compared with $35,000 for a hospital outpatient department – a difference of 24%.

But most of those savings have been consumed by the higher cost of the drugs, leaving the proportion of overall spending on cancer care largely flat. This transformation in care has similarly changed the business of oncology. It has boosted profits at the drug makers, but come at the expense of academic hospitals.

These trends, from the inpatient to outpatient care of cancer, shouldn’t obscure the fact that the high costs of the new drugs create many hardships for individual patients. When a drug has a price tag of $100,000 for a single round of treatment it can saddle patients with substantial costs as a result of the required co-payments.

But this is as much a problem with insurance schemes as it is with the price of the drugs. Most of us treat health insurance as pre-paid medical care, and are over-insured for routine matters, and under-insured for catastrophic illness like cancer.

Moreover, most insurance plans cover hospital admissions far better than they cover care delivered in the community, especially specialty drugs. To realize the savings that come with shifting care out of acute facilities and into homes, this incongruity in how insurance schemes are structured must be fixed.

If a drug improves outcomes and lowers costs (by shifting care from inpatient to outpatient settings) then that value will get baked into the price of the medicine.

The cancer drugs get a lot of focus not only because of the high and easily quantified prices, but also the growth in those costs. Spending on cancer drugs rose at an annual rate of 6% between 2007 and 2011. But it’s still a small component of total costs. Aggregate spending on cancer drugs is only about .8% of our total healthcare budget. So even as it grows, its impact will be subtle. Of that .8%, a little less than half is spent on the old-line, and much cheaper generic chemotherapies.

Drug Innovation 12: H7N9, SARS, Bird Flu and Vaccines

Today, I read three stories of the SARS-like virus that has affected Saudi Arabia, and bird flu virus in  China.

Some 15 people have already died in Saudi Arabia alone, from SARS-like coronavirus. There are some panic especially in the eastern part of the country. See the news here.

A follow up article, also today, New SARS-like virus can probably pass person-to-person. In one family alone in Eastern Saudi Arabia, the father died and the three children got sick too with similar symptoms, two are in the ICU already. 

Then the news in China with 35 deaths already from a strain of H7N9 bird flu virus, out of 130 reported cases. News story here. All these three stories are from interaksyon.com.

Diseases indeed mutate. They are not dead or static, they are living and evolving micro organisms that want to expand themselves as fast as possible and claim more victims.

And that is why medical treatment, medicines and other aspects of healthcare must continue to evolve too. And some government policies that can discourage such continued innovation should be discouraged instead.

Reiner Gloor of PHAP has two articles last month on vaccines and preventive healthcare, especially in protecting children. Posting them below.

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http://www.bworldonline.com/content.php?section=Weekender&title=R&D-supports-Decade-of-Vaccines&id=68873

Posted on April 18, 2013 05:51:09 PM

Medicine Cabinet -- Reiner W. Gloor

R&D supports Decade of Vaccines

PREVENTING diseases remains the most important health strategy that eliminates the burden of social and financial risks associated with curative or palliative care. Vaccination has saved about 2.5 million lives each year, making it one of the most important and cost-effective public health innovations.

The 65th World Health Assembly (WHA) acknowledged, “vaccination is, and should be recognized as, a core component of the human right to health and an individual, community and governmental responsibility.” The WHA added that as an integral part of a comprehensive package for disease prevention and control, vaccines and immunization are investment in the future of a country.

In the Philippines, President Benigno Aquino himself recognized immunization as part of his priority universal health care agenda. He said that to win the war on poverty, the country must also turn its attention to public health.

“And, as we focus on the health of our country, economy, government, the overall health of all Filipinos also remains a top priority. We want our people to be empowered individuals capable of standing on their own two feet -- strong, healthy, and skilled men and women who can take advantage of the opportunities that life affords them,” he said during the launch of the an immunization program targeting 700,000 poor children.

Introduced at the World Economic Forum in Davos, Switzerland in January 2010, the global health community made a call for a Decade of Vaccines (DoV) which vision is a world in which all individuals enjoy lives free from vaccine-preventable diseases. The mission of the Decade of Vaccines is to extend, by 2020 and beyond, the full benefit of immunization to all people, regardless of where they are born, who they are, or where they live.

The Bill & Melinda Gates Foundation pledged $10 billion for the research, development and delivery of vaccines for the world’s poorest countries. The Foundation projected that about 7.6 million children under five will be saved from life-threatening diseases by increasing vaccines coverage in poor countries by 90%.

Drug Innovation 11: They Create Cures or Customers?

The pharmaceutical industry -- mainly grouped between the innovators and the generic producers, but often associated with the former -- always evokes lots of emotive comments, factual or not. Like this image below, posted by "Juicing Vegetables" page in facebook last Sunday.

As of this writing (9:20am, Manila time), it has attracted 6,667 likes, 7,117 shares, and 212 comments.

I am posting below some of those comments. They offer a wide variety of perspectives and opinions. Should be useful to both the pharma industry and its detractors/haters. You may see 212 comments in facebook here. It should become 300+, 500+ later. Enjoy
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Glen Kolenc It's naive to think a whole industry can exist without making a profit. I wouldn't work in any industry or job for nothing. Really this is business 101 - a business must profit to survive! Just because pharmaceutical companies profit, doesn't mean they aren't doing something for the good of people.

I also think its naive and irresponsible to think that pharma companies are responsible for our health. We need to take matters into our own hands.... If you are unwell, do as many healthy/natural remedies as possible but also go to the doctors. Take medicine if u need it but don't blindly think a tablet will cure everything. But don't be a fool & ignore the fact that medicines do save lives

(Replies)

Patricia Bruch We're all human guinea pigs. They get rich and some of us survive with no lasting effects. I understand they have to make a profit but at what cost? There are so many side effects from many of the pharmaceuticals out there that you have to wonder is it worth the risk? I for one did not take a prescribed medication because I really want to keep my Esophagus. It was stressed to me several times that erosion was a common side effect. Why would I take it??? 

 Julia Robinson Randolph My husband works for Abbott/Abbvie. He has never once decided to become a scientist for the profit!! He wanted to be a positive influence in this world. There are plenty of diseases out there that cannot be helped by nature alone and need help from medicine. Many meds. are not just chemicals either....Scientist work with nature as well. My husband has a PhD and went to school plus internship for over 10 years to make meds to help very serious diseases!! The amount of money it costs to make a single pill to help desperate people is amazing. There are other people such as celebrities, athletes, political folks, and bankers who make ten times more money than my husband, more actually. We are only middle class and struggle to make payments on bills like everyone else!! Stop poking at the pharma companies for without them, we would all be in serious trouble!! Nature needs alot of help!! I wish I could publicly tell you all that my husband has helped discover for many people's benefit, but I can't...Please stop making my husband look like some sort of profit monster bec. he works many, many hours to help others, and we do not drive new cars or have a million dollar home. 

Terri Basting He is probably a noble man, but somebodys getting rich at the cost of many. 

Aloysius Nelson those that involve in the profit gaining of prescription drugs,and those that support them,will never admits that over the counter drugs cause more problem to people more than it solve them,so who is the naive one? 

Yvone Fuqua It's not that they are making money, it's that they are HELPING the largest ELITE to BLOCK cures when all...... and I MEAN ALL of this was created IN the FOOD PROCESSING. MORE JUNK = MORE ILLNESSES.............. it's called POPULATION CONTROL in all reality. POOR can't afford the 150-200 a WEEK per PERSON to eat HEALTHY - I discovered this Cost and THANKGOD I have assistance to RECLAIM and REGAIN my health!

Angela Demars Roberts Unfortunately you are probably right about your husband, but that is because he is the one who does the work. It is the people employing him who are making the millions, while the middle class slave away trying to do something worthwhile. Also unfortunately the medications that actually help save lives are few and far between and are usually the ones that are used infrequently, not the ones sold as a daily use prescription. And indeed the diseases that might actually seem to warrant a daily prescription are definitely caused by what we are doing to ourselves!! Diet, toxins, etc.

Mary Velez sooo true
After the first pill,.. there's always 20 more bottles to"cure" the damage the first one made.

Christafer Duran "There's no money in the cure. The money is in the medicine. That's how a drug dealer makes his money. On the come back."

Robynne Lewis Ok sheeple. Let me know how it goes when you try to explain that to the parents whose child was murdered by someone suffering from a psychotic break whom could've been successfully treated with antipsychotic medication. It's a blanket statement to say that ALL medications are equally unneccessary. Open your minds - learn the facts for yourself rather than pressing "like" simply b/c you might not require life saving medication at this moment in time. Diet and exercise are critical to health but they're not a cure all, especially when it comes to brain abnormalities.

Drug Innovation 10: Cancer, H7N9 and Government

Various types of cancer is among the leading causes of mortality (death) and morbidity (sickness) in the Philippines and around the world. It is a non-infectious or non-communicable disease (NCD) that is caused more by genetics and/or lifestyle. For instance, tobacco-related lung cancer, and alcohol-related liver cancer, are the top two killers among cancer for men in the Philippines, according to the article by Reiner Gloor of PHAP below.

A friend in the free market movement here, Joshua Lipana, died this week at a young age of 21, due to a rare and aggressive cancer (T-Cell Lymphoblastic Lymphoma). I mentioned a few times here that my own elder brother died of prostate cancer, and his wife (my sis in law) died of colon cancer, several years ago.

As medical science improves, discovery of more rare diseases that used to be lumped or identified with other diseases is becoming easier. But treating them is another matter and will not be easy. Reiner however, says "researchers are working on more than 800 innovative medicines that are either undergoing clinical trials or regulatory review. Due to these developments, cancer can now be better managed and even beaten."

Then early this month or late last month, we read a new strain of bird flu, the A(H7N9) that the WHO called as "one of the most lethal so far". Not as lethal perhaps as the A(H1N1) strain that killed more than 300 people middle of the last decade.

These H1 and H7 strains, unlike cancer or hypertension, are infectious or communicable diseases. Infection usually starts from chicken and other birds, to humans. So the immediate action is isolation of the patient from the rest of population to prevent further infection, while treating the patient.

Government has an important role in controlling infectious diseases, like detecting and isolating infected people who travel from one country to another through airport medical screening. But government, I believe, has little role in controlling NCDs as these are usually difficult, complicated and expensive to treat diseases, requiring more personal responsibility (remind people that over-eating, over-drinking, over-smoking is not good for their health). If government will put more resources on controlling NCDs, it will further worsen already high public indebtedness, which will have negative effect on other public spending over the long term, like spending to maintain peace and order and ensure a credible justice system.

And of course, governments should not make the business and scientific environment antagonistic to drug innovation. They should not politicize innovation and reward rent-seeking via IPR-busting policies.

Below are two articles by Reiner of PHAP, about cancer and H7N9.. Reposting from BusinessWorld. Enjoy.
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http://www.bworldonline.com/weekender/content.php?id=46080

Posted on 06:05 PM, February 02, 2012 

Medicine Cabinet -- By Reiner W. Gloor

Beating cancer

Major non-communicable diseases were among the important health issues that gained the attention of world leaders in 2010. In a United Nations summit, political leaders agreed to a plan of action that sought to address alarming trends involving four major non-communicable diseases (NCD) that have developed to become the world’s biggest killers.


The four major NCDs are cardiovascular diseases, diabetes, chronic respiratory diseases, and cancers that have altogether prematurely claimed the lives of 38 million people, representing about 63% of the total global deaths in 2008. Studies indicate that the major NCDs are affecting the developing world and lower-income populations hardest.

This is particularly true for cancer, which accounted for about 7.6 million global deaths in 2008. By 2030, cancer deaths are also expected to soar to 11 million worldwide. The World Health Organization (WHO) also disclosed that about 70% of all cancer deaths occur in low- and middle-income countries.

Cancer can affect any part of the body. A defining feature of cancer is the rapid creation of abnormal cells that grow beyond their usual boundaries, and which can then invade adjoining parts of the body and spread to other organs. This process is referred to as metastasis which is the major cause of death from cancer, the WHO said.

Locally, the Department of Health recently led the observance of the National Cancer Awareness Week in a campaign to boost public consciousness on the disease. Such an awareness drive is important specifically for the Philippine Society of Medical Oncology (PSMO), which considers information as a keystone to preventing and treating cancer.

The need to raise awareness on cancer has become more evident with the GLOBOCAN Project report, which estimated that there had been more than 51,000 cancer deaths in the Philippines in 2010.

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

Among Filipino men, lung and liver cancer comprise 43% of all new cancer deaths. These top two killer cancers affected more than 12,000 Filipino men.

Drug Innovation 9: Treating Lympho Leukemia and HIV/AIDS

I like this story from the NYT although this was published half year ago. A dedicated scientist at Washington University studying human gnome and lympoblastic leukemia has developed the same cancer that he is personally studying. and subsequently weakened him, awaiting death. His colleagues in the research team set aside many things they were doing and focused only on one thing -- find out what is that disease, how it developed, and how it can be killed. Below is portion of that news report.

http://www.nytimes.com/2012/07/08/health/in-gene-sequencing-treatment-for-leukemia-glimpses-of-the-future.html?_r=0

...Dr. Ley’s team tried a type of analysis that they had never done before. They fully sequenced the genes of both his cancer cells and healthy cells for comparison, and at the same time analyzed his RNA, a close chemical cousin to DNA, for clues to what his genes were doing.

The researchers on the project put other work aside for weeks, running one of the university’s 26 sequencing machines and supercomputer around the clock. And they found a culprit — a normal gene that was in overdrive, churning out huge amounts of a protein that appeared to be spurring the cancer’s growth.

Even better, there was a promising new drug that might shut down the malfunctioning gene — a drug that had been tested and approved only for advanced kidney cancer. Dr. Wartman became the first person ever to take it for leukemia.

And now, against all odds, his cancer is in remission and has been since last fall.

While no one can say that Dr. Wartman is cured, after facing certain death last fall, he is alive and doing well. Dr. Wartman is a pioneer in a new approach to stopping cancer. What is important, medical researchers say, is the genes that drive a cancer, not the tissue or organ — liver or brain, bone marrow, blood or colon — where the cancer originates.

One woman’s breast cancer may have different genetic drivers from another woman’s and, in fact, may have more in common with prostate cancer in a man or another patient’s lung cancer. 
Under this new approach, researchers expect that treatment will be tailored to an individual tumor’s mutations, with drugs, eventually, that hit several key aberrant genes at once. The cocktails of medicines would be analogous to H.I.V. treatment, which uses several different drugs at once to strike the virus in a number of critical areas....
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A combination of genetics science and pharmaceutical science is key to treating certain diseases, especially new or emerging ones. Which brings us to the importance of more medicine innovation and how it can be encouraged, or at least how now to impede it via more politics and more government intervention, like dishonoring intellectual property rights (IPR) like drug patents.

Below is another story on medicine innovation to treat HIV/AIDS. The good news is that more and more medicines and vaccines from more drug manufacturers are coming on stream. Since they are different from each other, both off patent and still patented, patients and health professionals can expect competition among them, both in efficacy and prices. Generic producers can help tighten the competition once newly invented drugs and vaccines have become off patent. The important thing is that someone or some firms must invent those new drugs first, assume all the risks and high cost of R&D. Once they are proven to be useful and safe, generic producers can come in later to produce new brands of the same useful molecules against HIV/AIDS.

More science, more innovation, and less politics. Public health and life expectancy are expected to be improving through time.
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http://www.bworldonline.com/content.php?section=14&title=R&D-to-combat-HIV/AIDS&id=62556

R&D to combat HIV/AIDS

Posted on December 06, 2012 06:44:33 PM

Medicine Cabinet -- Reiner Gloor

“GETTING TO ZERO” new HIV infections and zero deaths from AIDS-related illnesses may sound difficult to achieve but significant progress in the prevention and treatment of HIV/AIDS is providing hope for patients and their families.

In time for World AIDS Day on Dec. 1, biopharmaceutical companies announced that around 73 medicines and vaccines are in the pipeline for the treatment and prevention of HIV.

The Pharmaceutical Research Manufacturers and Associations (PhRMA) reported that these are centered on improving treatment regimens, more effective therapies and promising new preventative vaccines.

Between 2011-2015, the World AIDS Days will have the theme of “Getting to zero: zero new HIV infections. Zero discrimination. Zero AIDS related deaths.” This highlights the need for greater access to treatment for all.

Nearly 40 medicines have been approved to treat HIV/AIDS in the past 30 years. There have also been advances in the diagnosis of the disease, allowing for earlier treatment and care.

The World Health Organization (WHO) attributed many of the gains to life-saving antiretrovirals that reduce the amount of virus in the blood so that patients has increased chances of staying healthy and have less risk of passing the virus on to others.

HIV can be suppressed by combination antiretroviral therapy (ART) consisting of three or more antiretroviral (ARV) drugs. While ART does not cure HIV infection, it controls viral replication and allows an individual’s immune system to strengthen and regain the capacity to fight off infections (www.who.int).

Even with the progress, there remain great opportunities to intensify research for better treatment and prevention of the disease. Until now, there is no cure for HIV/AIDS.

The WHO said that HIV has claimed more than 25 million lives in the past three decades. Globally, about 34 million people are living with HIV in 2011.

In the Philippines, there were 295 new HIV positive individuals confirmed by the STD/AIDS Cooperative Central Laboratory in October this year, or 48% higher compared to the same period last year. In January to October this year, there were 892 more new HIV cases, 48% more compared to the same period in 2011. The significant increase was observed starting July 2011 onwards, mostly breaching 200 or even 300 new cases per month.

The Department of Health-National Epidemiology Center (DoH-NEC) reported 2,761 HIV cases, of which 148 were reported AIDS cases, from January to October this year. Around 748 young people (15 to 24), and four children below 15 were part of this total national figure.

It added that from 1984 to 2012, there were 11,125 HIV cases in the Philippines with 1,130 AIDS cases. More than 350 people in the country have died from AIDS since 1984.

In support of the Millennium Development Goal 6 to stop or reverse the incidence of HIV/AIDS by 2015, the government through PhilHealth, has rolled out an outpatient package to increase patient access to treatment and education. First implemented in 2010, the Out-Patient HIV/AIDS Treatment (OHAT) Package aims to provide patients access to ART and the benefit was later expanded to include treatment for tuberculosis.

In the battle against HIV/AIDS, PhRMA reported that medicines in development include a gene therapy that uses genetic material to remove disease-causing aspects of the virus; a transdermal vaccine that helps suppress virus replication and destroys HIV-infected cells; and a first-in-class medicine intended to prevent the HIV virus from breaking through the cell membrane.

Many of the medicines are in Phase I and II of the long, expensive and complex drug discovery process. Phase I of the clinical trial involves a small group of people, usually between 20 and 80 healthy adult volunteers, to evaluate a drug’s initial safety and tolerability profile, determine a safe dosage range, and identify potential side effects. Phase II is the stage in which the drug is given to volunteer patients, usually between 100 and 300, to see if it is effective, identify an optimal dose, and to further evaluate its short-term safety.

When a candidate drug reaches Phase III, it is given to a larger, more diverse patient population, often between 1,000 and 3,000 patients or more, to generate statistically significant evidence to confirm its safety and effectiveness. They are the longest studies, and usually take place in multiple sites around the world (For the full report, go to www.phrma.org).

Biopharmaceutical companies have expressed commitment to continue research to prevent or treat HIV/AIDS. Policies and collaborations that encourage innovation and healthcare access are critical to this mission

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See also: 

Drug Innovation 5: The US PCAST Report on Propelling Drug Discovery, October 20, 2012

Drug Innovation 6: Dealing with Drug-Resistant TB, November 30, 2012
Drug Innovation 7: IFPMA, Superbugs and Tropical Diseases, December 04, 2012
Drug Innovation 8: Treating Men's Cancer, December 20, 2012