Garam Tea Chat

By Doug Bremner

While it’s true that many drugs help people live longer and better lives, myriad others may hurt you in other ways that you don’t know about. Pharmaceutical and supplement manufacturers have to increase sales and profits, as all businesses must, and they do so in part by developing drugs to treat disease and also by convincing people they need meds to prevent disease or lessen the perceived risk of future illness. The result is that nondisclosure of potentially harmful side effects of the drugs they make has become routine.

In 1992, the Prescription Drug User Fee Act (PDUFA) stipulated that a fee (now $576,000) be paid to the FDA by the pharmaceutical companies for each new drug application. The number of staff at the Center for Drug Evaluation and Research (CDER) doubled overnight. Today, the FDA receives about $260 million a year from these fees. Part of the bill stipulated that funding by Congress for new drug evaluations had to increase by 3% per year. Since the overall funding for the FDA did not increase at 3% per year, the FDA had to actually cut funding for surveillance and research of approved drugs. This has been a boon for drug makers, approval time of their products decreased from 20 months to six months right after the law changed. However, the number of drugs that had to be later withdrawn also increased from 2% of drugs to 5% of drugs.

There is another troubling dichotomy that could have terrible repercussions for our health: while the number of people with disease is not growing, the number of adult Americans taking medication is increasing - half of us take prescription drugs and 81% of us take at least one kind of pill everyday - and that percentage is expected to rise in the coming years. To gain the most market share, companies have to invent drugs for diseases that previously had no treatment (or treat problems that may not necessarily require drug treatment, or create prevention medications for alleged risks (like the risk of fracture in the elderly) by expanding the potential pool of medication takers. That meant moving from the realm of giving medications to sick people, to giving medications to people who looked well, but might be at an increased risk based on the result of a blood test or some other hidden marker of disease. Thus the era of disease prevention and risk factor modification was born.

To promote this shift, for the past two decades the pharmaceutical industry has pushed educational programs, which they claim are designed to identify people in need of treatment or prevention with medication. This is usually done by donating money to organizations who advocate on behalf of a specific disease who will in turn “get the word out,” increasing public awareness and screening, and expanding the number of individuals who will potentially take the medication. There are a number of conditions for which we are now urged to obtain screening and potential treatment, including high cholesterol, osteoporosis, hypertension, diabetes, and undetected heart disease. However, the potential benefit of medications to treat these conditions is often exaggerated, side effects are minimized, and in some cases recommendations are applied to people based on evidence from different groups of people (e.g. women with risk factors for heart disease are urged to take cholesterol lowering medications based on studies in men).

Another factor that has expanded use of prescription medications happened in 1997, when the FDA lifted the ban on direct to consumer advertising along with the law that required ads to list every possible side effect. Soon after, Americans were bombarded daily with commercials for prescription drugs. The US is the only country in the world where you can turn on the TV and have an announcer tell you to go ‘ask your doctor’ for a drug. Doctors often will give medications to patients even if they don’t think they need it. For example, one study showed that 54% of the time doctors will prescribe a specific brand and type of medication if patients ask for it.

With so many of us popping pills or gulping down spoonfuls of medicine, it’s not surprising that more of us report related adverse effects. One hundred thousand Americans die every year from the effects of prescription medications. Over a million Americans a year are admitted to the hospital because they have had a bad reaction to a medication. About a quarter of the prescriptions that doctors write for the elderly have a potentially life threatening error. Many of these people are getting medications that they don’t need, or for problems that can be appropriately and safely addressed without drugs. For example, most cases of adult onset diabetes can be prevented and possibly cured with a change in diet alone - and with considerably fewer negative side effects and numerous healthy ones, like weight loss, and lower blood pressure and cholesterol. Drug companies buy information about the medications that doctors prescribe from major chain drug stores like CVS, and then use this information to reward doctors who prescribe their drugs frequently, with trips to resorts and other perks.

Drug companies also lavish dinners, gifts, and paid trips to conferences on doctors. Research studies show that, although doctors deny that the perks have any effect on their prescribing practices, there are changes in objective measures, like how often a doctor will try to have a drug from that particular company put on his hospital’s formulary.

I’m not saying that some drugs don’t ever successfully prevent disease, or that newly described diseases and syndromes are necessarily invalid. But the fact is that no matter how you look at it, the US (and to a lesser extent other countries) has a prescription drug problem. The US spends two times more on drugs, and takes twice as many drugs, as other countries, and has worse health. That means we are paying money for drugs that are not working for us.

Despite the fact that Americans spend twice as much on health care as any other country in the world, we have some of the worst healthcare outcomes in the industrialized world, including total life expectancy, and survival of children to their 5th birthday. In a survey of 13 industrialized nations, the US was found to be last in many health-related measures, and overall was 2nd to the last. Countries with the best health care included Japan, Sweden, and Canada, in that order. Factors that were thought to explain worse healthcare outcomes in the US included the lack of a developed and effective primary care system and higher rates of poverty. Even England, which has higher rates of smoking and drinking and a fattier diet, has better health than the US.

Because the drug companies are only required to show that the drugs are better than nothing we usually never know whether they are better than older drugs the new versions seek to replace. It is usually left to the marketing people to generate enthusiasm, through TV ads, product representative visits to doctor’s offices, and sponsored lectures, that the new drugs are safer or better than the old drug. They do this by picking some aspect of the drug’s properties that theoretically makes it better. But as we have seen with Vioxx and other drugs, they aren’t always better, and sometimes they carry hidden risks.

The head of the American Psychiatric Association recently bemoaned the fact that psychiatrists had gone from the “bio-psycho-social” model to the “bio-bio-bio” model. Us doctors have become mesmerized with the idea that all depressions are caused by imbalances of serotonin that can be fixed only with a drug that acts on serotonin. However most cases of depression are caused by life traumas, spiritual upheavals, and other jolts along the road of life. That isn’t to say that these changes aren’t accompanied by changes in brain chemistry: it is both. But I think it is time that we acknowledge the role of emotion and spirituality in mental disorders. It only makes sense.

Given medical scares like Vioxx it’s not surprising that Americans have become wary of the FDA and drug companies, and both of their public images are beginning to suffer. The Economist reported November 24, 2004 (”Lessons For Pharma From Tobacco”) that less than 50% of us perceive drug companies as “favorable.” That’s only slightly above the low favorable ratings we give oil and tobacco companies.

All this is not to say that many medications have not changed life for the better, particularly those that treat infections. However, ironically most recent health gains have come through increased knowledge of health risks and better health practices (or prevention). We smoke less, have better access to nutritious fruits and vegetables year round, pay more attention to cleanliness and hygiene, and have improved safety in general. For instance, in the 19th century it was not known that dirty water and shared cups could spread disease. Hand washing is still the single most powerful way to prevent the spread of communicable disease, but this was not discovered until 1847, when Ignaz Semmelweis, a young Viennese doctor in an obstetrics ward, observed that midwives who washed their hands had lower mortality rates among their patients than doctors, who often went from autopsy room to delivery ward without so much as a hand wipe.

Future advances in health will likely come more from changes in lifestyle, diet and exercise, than from medications. Almost all of the chronic conditions for which pills are prescribed are preventable through such changes. Other conditions like cancer are partially preventable.

It is time for Americans to rethink the role of medications and other pills in their lives in relation to other actions that can be taken to maximize health, such as making changes in diet; incorporating exercise into one’s daily routine; learning and using stress reduction techniques; and changing other behaviors like quitting smoking. The most common disorders, like diabetes and heart disease, are always better treated and prevented through changes in diet, exercise, and lifestyle that they are with medication. Pharmaceuticals can be life saving for some conditions, such as insulin for Type I diabetes, thyroid hormone for hypothyroidism, or antibiotics for life threatening infections. All of this has been shown through several scientific studies. Before you take a pill, consider taking charge of your health by making informed decisions and smart changes in your lifestyle. In some cases, however, you may need medications for prevention or treatment of disease, or to help you with troubling symptoms or disabilities. In those cases you should know as much as you can about the risks and benefits, so that when it is time to talk to your doctor you can make an informed decision that both of you are happy with.

Author Resource:- Learn more about alternatives to medications and hidden risks of prescription medications in http://www.beforeyoutakethatpill.com by researcher and physician J. Douglas Bremner, MD. Reprinted with permission from http://www.articlehealthandfitness.com/

By Achamma Chandersekaran 

I had met Tina at my nephew’s house while visiting my native village of Arthunkal in Kerala. She used to come there everyday to prepare meals for the family. She was a pleasant woman who could make delicious dishes.    

One day I met her daughter, a beautiful young girl studying in the fifth grade. She was a good student and did well in all subjects, except English, her mother said. I told her that I’d help her with English if she came to the house. She could come only a couple of times. During school days, especially during the Makaram Festival at the local church, it was not easy to fit this into her schedule. But I had established a good relationship with the mother and daughter. 

Two years ago Tina came to me a couple of days before I had to leave and asked for a loan of Rs.10,000 to fix up her house, promising to return it the next year. I had spent all the money I had taken and asked her why she didn’t make the request earlier. We agreed on “may be next year.”  But I was not comfortable with that decision. Who knows who would be there a year later?  Who knows if I would go at all the next year?  So I deposited a dollar check in my account at the local branch of the State Bank and arranged for Tina to get the 10,000 rupees. 

After I retired from the U.S. Department of Commerce in 2000, I went to India for two months every year, supposedly to get away from the winter here in the East Coast. But invariably winter would wait for me to get back in the middle of February and give me a taste of the chill. I went last year also. Since my nephew passed away during the year, one of the first things I did was to go and visit his wife. Tina was still there and said that I should have called to say that I would be visiting. She had to return the money to keep her word. I told her that she could give it to me any day before I went back. Within a few days, when I called my niece about my planned visit, she told me that Tina had brought the money and left it with her so that I could get it whenever I went there. I appreciated Tina’s determination to keep her word. 

When a grandnephew who had borrowed money from me was making excuses for not returning it, though he had been in a high paying job for a couple of years, I sent him an e-mail and said:             

“Last year, the woman who has been making meals at Kenny’s house had borrowed 10,000 rupees from me saying she would return it this year. True to her word, when she learned that I was at Arthunkal she brought the money and paid me back. I realized that one doesn’t have to be rich or educated or from a “good family” to have credibility. Sometimes one has to learn from the uneducated poor.” 

The young man was obviously furious and I got an immediate response that included the following: “ur microfinancing business and cheap tricks wil run well in akl, among illiterate fishermen … thatz y u hav built an inflated brand for yourself in that tiny insignificant village… but only among those innocent folks… Remember, bubbles dont last long!” 

He can have his opinion. I was not helping people with any ulterior motive and my email was only a factual statement. What he borrowed is yet to be paid back. 

When summer vacation started this year I called Tina to find out how her daughter was doing in school. Last year she had told me that the girl did well in all subjects, even English. But she still had difficulty with Math. So I asked Tina to arrange for someone to tutor her during the summer so that when she would get to the ninth grade in June she wouldn’t feel lost. After many attempts I was able to talk to her and get her to agree to do that.  

During the conversation she told me that she had to borrow the money she returned to me at almost 20% interest to return it on time. I was flabbergasted, didn’t know what to tell her. One reason why I loaned the money was to keep her away from the loan-sharks. When I asked her why she didn’t tell me about all this she said, “I had promised to return it in a year and that was the only way I could keep my word.”  According to her, most of the fishermen folks in the village lived hand-to-mouth. When they needed extra money for something urgent like fixing the roof before the monsoon season, the loan-sharks would be ready with the money for an exorbitant rate of interest. She had also pawned her gold chain because the house repair needed Rs. 40,000. From what she told me I don’t think she would ever be able to get her jewelry back.  

Since that conversation, I had been wondering how I could help her. After thinking of different ways, I came up with one idea: based on a CD I have at the State Bank, I can arrange for her to get a loan at about 6.5% interest. As she is meticulous about keeping her word, hopefully she will pay back the loan in three years (a bank requirement.) 

It is no fun being poor. This is one reason why I want her daughter to study well and get a job so that this hand-to-mouth existence will end with this generation.  Before going to bed, I talked to the bank manager and sent an e-mail to the bank asking them to loan Tina Rs. 20,000 (she asked for 20k instead of 10 to consolidate her debts), keeping my CD as security. The CD is going to be there anyway, I thought, there is no harm in someone in need benefiting from it – as long as they keep their side of the deal of paying back on time. 

Achamma Chandersekaran is the translator-author of Daughters of Kerala, a collection of short stories by award-winning Malayalam authors. She has presented a copy of her book to the Pope. You can visit her at www.achammachander.com