FDA Approval, ? Blanket Approval

When drug companies try to convince doctors about their product, they always cite that their drugs have been approved by FDA. But what some doctors do not know is that FDA approval is based on short term safety only. Most studies are conducted for 6 to 8 weeks. Whereas serious, long-term side-effects of drugs take years to emerge.

For approval of new drugs, FDA has a professional staff of 1500 doctors, scientists, toxicologists and statisticians. But to monitor the safety of more than 3000 drugs already in the market and being prescribed to millions, the agency has a professional staff of just 5 doctors and one epidemiologist.

FDA budget is set by Congress and Congress is under intense pressure from lobbyists for the pharmaceutical industry to weaken rather than strengthen drug testing and monitoring for reasons well known to business community.

As a researcher myself and involved in many drug researches, I want my doctors to understand this when confronting pharmaceutical representatives so that they have a balance view on both side of the story. And finally it is the safety of patients is of utmost importance.

Definition of Success

1. I overheard two good friends talking. The first man was telling his friend, “You have many good potentials to succeed but you seem to put things to a stop”. His friend was puzzled, ceased talking for a moment, took a deep breath and replied, “Success means differently to different people”.

2. Then I realized, to most people success means having millions in the bank, drive the best car in town, live in bungalows in Bukit Tunku or publish their works in the Lancet.

3. To others, success refers to when they appreciate their life to the most and never waste every single little thing out of it. To them, it is about having a happy family, a good wife, fantastic kids and enjoy every second being with them are what they meant to be successful.

4. Seeing kids grow in front of their eyes is a fantastic moment for most parents. Being able to guide them through the most wonderful year of their life is a dream not to be missed.

5. That explains why some mothers are willing to give up their jobs, simply for a reason; to bring up their kids. To them, success in life is when they see their lovely children grow-up to become successful adults and charming husbands or wives with the ability to reproduce the next generation, provide them with good education and therefore prolonging the legacy of the family.

6. I believe that if those are the definition, the friend wouldn’t feel depressed and at least he can lead a fulfilling life right after the meeting.

On The Possibility Of A “Fourth” Sexual Orientation

Some scientists believe that there may be a fourth sexual orientation in our species, one characterized by the absence of desire and no sexual interest in males or females, only a complete and lifelong lacuna of sexual attraction toward any human being (or non-human being). Such people are regarded as asexuals. Unlike bisexuals, who are attracted to both males and females, asexuals are equally indifferent to and uninterested in having sex with either gender.

In one recent interview study published in a 2007 issue of the Archives of Sexual Behavior, a group of self-described asexuals was asked how they came to be aware they were different. One woman responded:

I would say I’ve never had a dream or a fantasy, a sexual fantasy, for example, about being with another woman. So I can pretty much say that I have no lesbian sort of tendencies whatsoever. You would think that by my age I would have some fantasy or dream or something, wouldn’t you? … But I’ve never had a dream or a sexual fantasy about having sex with a man, either. That I can ever, ever remember.

In another interview study, this one by University of Michigan researcher Kristin Scherrer, an 18-year-old woman put it this way:

I just don’t feel sexual attraction to people. I love the human form and can regard individuals as works of art and find people aesthetically pleasing, but I don’t ever want to come into sexual contact with even the most beautiful of people.

According to Brock University psychologist Anthony Bogaert, there may be more genuine asexuals out there than we realize. In 2004 Bogaert analyzed survey data from more than 18,000 British residents and found that the number of people (185, or about 1 percent) in this population who described themselves as “never having a sexual attraction to anymore” was just slightly lower than those who identified as being attracted to the same sex (3 percent). Since this discovery, a handful of academic researchers have been trying to determine whether asexuality is a true biological phenomenon or, alternatively, a slippery social label that for various reasons some people may prefer to adopt and embrace.

By all appearances most asexual people are normal, healthy, hormonally balanced and sexually mature adults who, for still uncertain reasons, have always found sex to be one big, bland yawn. Asexuality would therefore be like other sexual orientations in the sense that it is not “acquired” or “situational,” but rather an essential part of one’s biological makeup.

In Panic, You Hear Your Heart Beat. But How?

Scientists believe that an area of the brain, the interior and anterior cingulate cortex, is involved in what is known as interoceptive awareness—the awareness of our own physiological sensations, like a heart beating deep within your body.

But recent research from the University of Iowa has shown that we can also use another separate pathway when we consciously experience our internal physical states.

This second pathway, they believe, runs from the skin to the somatosensory cortex, which is the part of the brain that maps the external body.

The results came from a study with a neurological patient, “Roger,” who has been studied in the lab for 15 years, after suffering brain damage from herpes simplex encephalitis. Roger has nearly complete damage to his insula and anterior cingulate cortex, but his somatosensory cortex is completely intact.

Researchers injected 11 healthy male subjects and Roger with a synthetic form of adrenaline, which made their pulses’ shoot up by 25 beats per minute.

Roger felt his heartbeat as clearly as the other subjects, although slightly delayed. Researchers suspected Roger’s brain registered his heartbeats from the surface of his chest wall and from blood vessels pulsating under his skin. To confirm this they anesthetized his skin in specific areas, and administered adrenaline again.

The healthy subjects felt their heartbeat, as before. But Roger felt nothing.

This study suggests that both brain pathways are involved in interoceptive awareness, which can cover anything from a panic attack, to the sick-feeling of rejection, to a pounding heart from an afternoon pillow fight.

New ways of regulating dose given to patients: Individualized Medicine

Last year the official completion of the human genome sequence was announced, capping years of hard work. Now that the flashbulbs have dimmed, scientists are taking a hard look at the results. Benefits of the sequence were prophesied to include ‘magic bullet’ therapeutics, individualized medicine, and the prediction of disease long before symptoms surface.

But to realize these breakthroughs, we must fashion the four-letter code we all share into tools physicians can use, and ensure that these tools are readily available. Although one graduate student can now make huge strides with access to the Internet and basic molecular biology equipment, true success may demand nothing short of entirely new methods of clinical study and reorganization of existing academic structures.

The road to treatments based on genomic information has not been smooth, but clinical trials are underway for a number of new therapies. New methods of mutation screening are emerging, both for the genome and for the ‘epigenome’ layered onto it.

An understanding of the many mutations that underlie complex diseases and adverse drug reactions is now in our sights, aided by a large international effort to define the differences between our individual genomes. And the availability of genome sequence from our close and far evolutionary relatives is helping us to decipher the signals of genes and regulatory elements from the noise of background DNA, which is not yet fully understood.

Eat Fish, Get Protection From Heart Disease

The evidence for the cardioprotective nature of omega-3 fatty acids is abundant, and currently available data indicate that patients with known coronary heart disease should consume at least 1 g daily of long-chain omega-3 fatty acids from either oily fish or fish-oil supplements, and that individuals without disease should consume at least 250–500 mg daily. However, this area of research poses two questions. Firstly, which is the best source of omega-3 fatty acids—fish or fish-oil supplements?

Secondly, are recommendations for omega-3 supplementation warranted in view of the rapid depletion of world fish stocks? The argument that eating fish is better than taking fish-oil supplements stems from the fact that several important nutrients, such as vitamin D, selenium, and antioxidants, are missing from the supplements.

However, three major prevention trials have clearly indicated that omega-3 fatty acid capsules confer cardiovascular benefits and, therefore, that both are cardioprotective. Sustainable sources of omega-3 fatty acids will need to be identified if long-term cardiovascular risk reduction is to be achieved at the population level.

Men Are From Mars, Women Are From Venus

1. The differences between men and women are universal. Women complain that “he doesn’t understand”. “he doesn’t listen”. And men complain that “all she wants is attention.”

2. Women like affection from men. They like to be seen romantic.

3. Men like logic and they are objective. Women are emotional.

4. Men tend to do one thing at a time. Women do many things at a time.

5. Men have their own caves on which the sign states “Please do not disturb.” Women also have caves but the sign on their caves is “Please give me some attentions”.

6. 90% of women go into therapy because they want to be listened to and to be asked questions. They want to feel special. Men hate to be questioned and to be interrogated.

7. When a woman touches a man she may want to be attended to. But for a man anywhere he is touched he thinks that it has to lead to sex.

8. Men want to forget the problems of the day. Women want to remember. A man will say “Forget it, it’s no big deal.” For a woman she will not rest till the problem is talked about. Her response to the man, who wants to just forget about it and not make a big deal out of it, will be “How can you be so insensitive.”

9. Men should never tell a woman how she should feel. In fact if she is unhappy, the man needs to be unhappy with her for a while instead of offering advice.

10. Women make noises to get attention. Men make noises to signal “Please leave me alone.”

11. Men are efficiency oriented. Men want to do it the easiest and fastest way. Women on the other hand feel that taking the shortest path is boring. Women like variation. Men look good in a tuxedo or a suit. Women like to change their dress; many times in a day.

12. Men use their brain sequentially i.e. one part at a time. Whereas women are using the whole brain at once.

13. Women lower stress through talking and sharing. The collectiveness and togetherness which they share is part of their feminity. Men lower their stress by being alone. Women’s attitude is that if we can’t do anything about it then let’s talk about it and suffer together. Men’s focus is on solving the problem. And if they can’t solve the problem then they make the problem disappear by forgetting about it.

14. As women more and more enter into the workplace their need to being listened to and understood is not being met. The workplace is efficiency oriented. They are becoming more and more isolated, unseen and unheard. And this is causing them to go more and more into depression.

15. Women give more. Men want to get more.

16. Women want flowers to be purchased by men again and again. Men on the other hand feel that if they have done it once there is no necessity to do it again and again.

17. Sometimes the woman feels that she does everything according to what the man wants. They want to be appreciated on what they do.

18. When men delegate work to women, women want to be asked because silence is taken to mean ‘non-involvement’.

19. Men prefer women managers while they learn the job. Then, after learning the job they prefer male managers.

20. Men sprint faster. Women go for the long distance.

21. Women want sensitive men but when men become too sensitive, women don’t like it. They want men to be considerate but not too sensitive just like them.

Modified from article written by a fellow blogger, Vishwalok Nath. Sorry Nash, just pasted those points which I only agree with. Thanks.

Technical Problem

Blogger is currently under significant DDOS attack, and temporary prevention have been put in place to try to squash the attack. I would like to announce that the posting in Memperkasa Paradigma will be back once the technical problem resolved. The posting in The Writing On The Wall will be published as usual. Thank You for your attention. (13-Nov-2009)

Umrao Jan And Aishwarya Rai

I was talking to an honorable guest from Lucknow and relates a wonderful story based from a movie I watched on TV2 sometimes ago. It is an artistic piece of work, set in Lucknow, directed by J.P. Dutta’s adapted from the Urdu novel “Umrao Jan Ada” by Mirza Haadi Ruswa (1905). Here is the synopsis:

In 1840, eight year old Amiran (Bansree Mandhani) is kidnapped from her home in Faizabad by Dilawar Khan (Vishwajeet Pradhan) who had been sent to jail based upon the evidence presented by Amiran’s father. To take his revenge, he kidnaps Amiran and sells her to a brothel in Lucknow, run by Khannum Jaan (Shabana Azmi). She is adopted by Bua Hussaini (Himani Shivpuri) and Maulvi Sahib (Kulbhushan Kharbanda) who treat her as their own daughter. In the company of Khurshid (Ayesha Jhulka), Bismillah (Divya Dutta) and one of the courtesan’s sons, Gauhar Mirza (Puru Rajkumar), Amiran learns the art of being a courtesan.

The young girl turns into an elegant, poetic beauty by the name of Umrao Jaan (Aishwarya Rai). Umrao’s beauty and poetry is enough to catch the eye of Nawab Sultan (Abhishek Bachchan). The two begin a passionate romance, but when his father finds out he disowns Nawab Sultan from his life, wealth and property. The penniless Nawab goes to his uncle’s Nazimuddin in Grahi to sort himself out, and Umrao prays every day for his return.

With his absence, Umrao catches the eye of Faiz Ali (Sunil Shetty) who wants her at all costs. He extends a hand of friendship to her and asks her to accompany him to his home in Daulatabad, Umrao accepts but only after she finds out that they will be travelling through Grahi. After a confrontation involving Faiz Ali’s men and the soldiers of Grahi, the party are arrested including Umrao. Faiz Ali is revealed to be a dacoit who has been pursued for years. Nawab Sultan hears that Umrao and Faiz Ali are in Grahi and he meets Ali in the prison. Faiz Ali manipulates the information concerning his time with Umrao, and implies to the Nawab that they had a sexual relationship. The Nawab confronts Umrao and – feeling that she betrayed him – shuns her and sends her back to Lucknow. Heartbroken, Umrao attempts to return to her old life, but fate has other plans for her.

In a drunken state, her childhood friend Gauhar Mirza becomes frustrated and rapes her. Soon thereafter the British attack the city and she is forced to leave Lucknow; however, before doing so, she forgives Gauhar Mirza. She and the refugees then separate after she decides to go to Faizabad. Umrao goes to her childhood home, and finds out her father is dead.

She meets her mother and brother, but they refuse to accept her because of her profession. Umrao, shunned by her family, her lover and society, leaves to return to Lucknow, but fate plays another joke and on her way out the city, she encounters the man who kidnapped and sold her to the brothel in the first place. Poor, wretched, homeless and injured, the man begs for pity (not recognizing that she is Amiran), and she essentially forgives him. Shunned by all and having forgiven those who destroyed her life, she lives the rest of her days in Lucknow with her poetry and ill fate.