Generic Drugs Philippines 3: Dr. Alran Bengzon on Medicines

Dr. Alfredo "Alran" Bengzon at "3/4 of a century old" remains very sharp intellectually. He actually looks like late 60s, he has no white hair, unlike me, maybe he simply dyed it. Wisdom and humility is very obvious in the way he speaks: mild, clear and emphatic at times.

I attended a forum yesterday on Access to Medicines: Reminiscing the Past to Pave the Way for Universal Health Care sponsored by the Ayos na Gamot sa Abot-kayang Presyo (AGAP) Coalition held at Sulo Riviera Hotel, Quezon City. The event was co-sponsored by many other groups like the member-NGOs and POs of AGAP, and RiteMed/United Laboratories (Unilab).

The speakers before Doc Alran were:
1. Maria Mendoza, Executive Director of the Fair Trade Alliance (FTA), another coalition that is composed also of similar NGOs that belong to AGAP. She gave the Welcome Address.
2. Former MOH UnderSecretary Rhais Gamboa, now VP of Unilab
3. Olive Parilla of Homenet Philippines/PATAMABA, a member-NGO of AGAP (leftmost in this photo)
4. Elpidio Peria of BITS Policy Center, General Santos City, and
5. Susan Roces, Ambassadress of RiteMed, a famous actress many years ago (2nd from right). She repeatedly announced "Mag RiteMed na tayo." It was a big advertising for RiteMed/UL in the forum.
AGAP Convenor and former Senator Bobby Tanada rightmost.

The last three speakers gave testimonials on "How generics helped improved their living conditions/access to health".

RUM 3: On Combining Drug Molecules and Alaxan FR

After I posted RUM 2: SARAH, Drug Dependence and announced to several players and leaders in the Philippine health sector, focus shifted about drugs advertising and the molecular combination of paracetamol + ibuprofen of Alaxan FR. So I emailed the other day Dr. Suzette Lazo, a friend and Director of the Food and Drugs Administration (FDA, http://www.fda.gov.ph/) via our CHAT googlegroups, as well as Dr. Nazarita Tacandong, another friend and FDA Deputy Director. I wrote,

Hi Docs Suzette, Nancy,

When Doc Delen de la Paz asked during the DOH Consultative meeting on RUM, "Is it advisable to combine paracetamol + ibuprofen (Alaxan FR) in the first place", I did not ask for her answer but I can see that her implied answer is No.

Doc Isidro Sia also gave the warning of not taking that drug on empty stomach as there is high possibility of adverse health results, suggesting that the combination of those 2 molecules can be tricky.

Another physician friend commented today,

"In response to your question in your blog, it is irrational to combine paracetamol and ibuprofen in my professional opinion. This is an example of fixed dosed combination. But United Lab may have some scientific data to show efficacy, but I have never seen this. I wonder if BFAD then allowed this based on science or based on other reasons."

That's 0-3 score disfavor for Alaxan FR molecular combination. I am no physician nor pharmacist so I have to ask you this question, why FDA allowed such combination given the high use of that drug by the public?

Doc Suzette gave a reply, below. She gave me permission to post her reply in this blog. Meanwhile, here are some of the ads for Alaxan FR, a very popular pain reliever here mainly because of its endorser, Manny Pacquiao.

Noy, this drug has been approved by the FDA since the 80s. The requirement is that for fixed-dosed combinations to be approved they must be compliant on a number of things: show synergy (of efficacy), stability of components in combination, etc. So as this was approved, Alaxan must have complied. Of course, fixed dose combinations get rather contentious sometimes because of differing opinions, which may not hold much water unless supported by evidence. An important issue is if there's a safety problem here? Are (we) seeing cases of drug-related morbidity related to use of the drug? There's no data so far from the people who are criticizing it so where do we go from here?

For your info there are far worse preparations that have been approved and these things sell too. FDA is in the direction of working towards cleaning up the bundle of approved drugs but this wont happen overnight.

Suzette 

Health Transparency 4: Drug Promotions and Government

The Medicines Transparency Alliance (MeTA) - Philippines conducted a series of workshops for various groups and sectors on "Ethical Drugs Promotion and Marketing", August 31 to September 3, at the Asian Institute of Management (AIM) in Makati City. The workshop for civil society groups, consumer and patient groups, was held the other day, September 1, afternoon. Leaders of member-NGOs of the Coalition for Health Advocacy and Transparency (CHAT) like me attended the workshop.

The main resource speaker for all the workshop groups was Ms. Carole Piriou of Health Action International (HAI), a think tank based in Amsterdam. Carole gave a good presentation but I did not agree with some of her analysis and recommendations. We should get a copy of her powerpoint presentation in the coming days, but I took a photo of 2 of her slides.

Here is one of the slides of Carole. Based on some HAI surveys or studies, they say that "newer medicines are not necessarily better" as 69 percent of new (and patented) drugs are "nothing new." This assertion should get the attention and counter-arguments of the innovator pharmaceutical companies because the purpuse of medicine innovation is to develop more disease-killer drugs, or retain the original disease-killing capacity but with the minimum adverse effects. That should be "something new."

Another issue that Carole discussed, was that Continuing Medical Education (CME) via sponsored symposia and conferences by pharma companies for physicians have direct and positive correlations to increased prescription of the drugs produced by the sponsoring company.

I think that point is not surprising. I do not know if there is a neutral or independent body or organization that provides CME to physicians where all new drugs and vaccines from different innovator and generic pharma companies are presented and discussed in terms of their disease-killing capacity, any adverse effects, price, and so on.

In the absence of such independent group, then drug manufacturers will launch their own CME to certain physicians to explain about the properties of their new drugs. This has the indirect effect of active promotion and marketing, of course. If the manufacturers themselves will not do it and there is no independent body that will study and analyze the properties of new drugs coming out from different pharma companies, who will?

Dr. Kenneth Hartigan-Go, a former official of MeTA Philippines, now a professor of health management at the AIM, also gave a short presentation of the kind of promotions and marketing that some pharma companies advertise in media -- radio, tv, newspaper, and so on. The pictures that he showed were indeed very revealing. We hope to get a copy of his presentation in the coming days too.

An important consideration why many pharma companies resort to aggressive advertising and marketing, is because majority of Filipinos do not have outpatient health insurance card/organization. PhilHealth can be used only if one is confined for at least 24 hours. So since people do not have outpatient health insurance cards, they do not see a doctor for their minor diseases (fever, flu, headache, etc.) and get professional advice. People resort to self-medication -- like the drugs what they saw or heard on tv, radio, etc.

The biggest pharma company in the country is United Laboratories or Unilab. Its gross sales in April 2009 for instance, P25.8 billion, was slightly bigger than the combined sales of no. 2 (GSK), no. 3 (Pfizer) and no. 4 (Wyeth). Unilab is also the biggest drug advertiser in the country, its ads are visible in radio, tv, newspaper, billboards, and so on.

So, should government further regulate drug promotions to physicians and the public? My quick answer is No. When there is sufficient competition among various pharma manufacturers, among drugstores and among healthcare providers, that competition is the best regulator in terms of price, product quality, and corporate accountability.

Besides, the Food and Drug Administration (FDA, previously BFAD) has its staff over-burdened already with regulating everything from new (and/or imported) drugs to skin whiteners to fruit juices to processed/manufactured foods, drinks and soda, and so on. So to ask them to create a new set of regulations and monitoring system will simply raise public expectation and later, public disappointment.

Civil society organizations (CSOs) -- NGOs, people's organizations and coops, media, consumer groups, church groups, civic groups, etc. -- bonding into a big coalition can monitor drugs promotion and marketing. Then slam-dunk those firms that exaggerate the properties and healing power of their drugs. This public pressure and consumer vigilance is a more effective regulator than any combined government bureaucracies' regulation.

Huge drug firms laying off research staff

There was this news report last Thursday from Nature magazine.

http://www.nature.com/naturejobs/2009/091119/full/nj7271-375e.html

Published in Nature 462, 375 (18 November 2009) | 10.1038/nj7271-375e

Huge cuts by drug firms

R&D closure is the latest in a series of hits to drug companies.
Pfizer is closing 35% of its global research and development space, according to a 9 November announcement. The New York-based drug company, which employs 14,500 people in research and development worldwide, has said that R&D personnel cuts associated with the closures will make up a significant percentage of the 15% company-wide job cuts planned. Pfizer, which last month acquired US drugmaker Wyeth, has disclosed no further information and did not return phone calls by press time. In early November, US drugmaker Johnson & Johnson announced plans to lay off about 8,000, but did not reveal how the cuts would affect its R&D personnel.
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I asked guys in our local health coalition here in Manila, including those who favor bigger government intervention in healthcare, "Is this a good or bad development?"

No comment so far from any of them. For some people who dislike global capitalism in general, and big multinational pharmaceutical companies in particular, this should be seen as a positive development. New tools or policy schemes like compulsory licensing (CL) and drug price control are meant mainly to hurt the big multinational pharmas, not the local pharma. For instance, in the current drug price control policy, not a single product by United Laboratories (Unilab) was included, although Unilab is the biggest pharma company in the country, with sales equivalent perhaps to the combined sales of 2nd-3rd and 4th biggest pharma firms (GSK, Pfizer, Wyeth).

So if the big pharma multinationals are hurting, like even their patented drugs in the country are covered by price control, and the laying off of more than 1/3 of their R&D staff, in the case of Pfizer, then those who oppose big multi pharma should rejoice. Their goal is to publicly hurt, if not obliterate from the global economy -- using various government restrictions and regulations -- the big pharmas that they accuse of making huge profit at the expense of poor patients.

But those people do not realize, or at least they do not recognize, that those big pharma are the ones that invest huge money in high risk medicine innovation. The often glorified local, generic pharma companies do not risk their money and resources on medicine innovation, despite the fact that people around the world are demanding more innovative, more revolutionary medicines and vaccines.


Meanwhile, the US Healthcare Bill is 2,074 Pages Long...

I was surprised to read this update from Grover Norquist's facebook status, regarding the US healthcare bill. He noted,

"A word search of Sen. Harry Reid’s 2,074-page Senate healthcare bill (H.R. 3590) reveals that the term “tax” is used 183 times, “taxable” is used 164 times."

2,074 pages for a single bill? I doubt if even 10 percent of all US legislators will have the patience to read all pages of that bill.

Well, I'm not American, and I don't know most of the nuances of that bill. It's just the 2,000+ pages length of that bill that confounds me.