Monthly Archives: July, 2013

Medications: When Newest Isn’t The Best

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Big Bucks Can Sometimes Blur The Integrity of Scientific Studies

Its all very well for big pharmaceutical companies (pharmas) to release a new medication with a big bang , what with the enormous money invested in its research, development  and  production . However, not often enough, such new launches become unstuck when  unexpected side-effects appear after a few months on the market, despite the most strenuous prelaunch testing and extensive marketing as a blockbuster-to-be.

Unexpected side-effects aside, what’s potentially more serious is  when clinical trials (designed to prove a drug’s efficacy before its official launch) are falsified, thereby giving end-users erroneous data proclaiming (falsely) the drug’s efficacy. Such appears to be the case with regards to the Kyoto Heart Study.

What was the significance of this study? This study by Japanese scientists was greeted with great fanfare in 2009 and centres around the ability of a medication ,already extensively used for the treatment of high blood pressure, to reduce the possibility of getting stroke by 50% when used in high-risk patients. This was a milestone in drug treatment for hypertension and enabled the maker, Novartis , to make it one of the best-selling drugs in the world.

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The drug itself, valsartan, which is marketed as Diovan has been on the market since around 2001 for the treatment of hypertension and belongs to the new group of ARBs (angiotensin-receptor blockers). In fact, its patent expired in 2012, thereby enabling any pharma to produce its own version, so-called generic drug.

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Dr Hiroaki Matsubara, of the Kyoto Heart Study

And now the bombshell: Last Friday, Japan’s minister of health, Norihisa Tamura, as well as university officials at Kyoto Prefectural University announced that the Kyoto Heart Study data were “very likely” fabricated, Apparently, incomplete data was used and some of the scientific investigators were in fact employees of Novartis.

The reaction to this has been deafening. the respected European Heart Journal retracted the study from its 2009 issue. There has been widespread condemnation among medical circles, resulting in the resignation of the principal Japanese investigator from the Kyoto University, Dr Matsubara.

This episode puts into perspective the over-reliance of the efficacy of new medications on so-called landmark scientific studies, whose integrity may be subject to the temptations of big bucks and commercialism. Often, the losers are the consumers themselves.

 

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The World’s Best Hospitals – How To Be One

Lots of hospitals claim to have world-class facilities and boast of being the region’s best, but what really does it take to be one? The mere presence of a five-star hotel lobby with expensive chandeliers and smiling receptionists definitely is not one criteria. Lest we forget, people come to a hospital with a problem they want fixed; the rest are just superfluous and complementary.

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The lobby of Chiangmai Ram Hospital, Thailand.

The best medical centers for the most difficult patients – that’s how the US News & World Report decides which are the best hospitals in the US, for example. They have been publishing annual rankings of the best hospitals in the US since 1991. The latest list was released last week:

US News & World Report Top Hospitals Honor Roll 2013

1. Johns Hopkins Hospital, Baltimore, Maryland

2. Massachusetts General Hospital, Boston

3. Mayo Clinic, Rochester, Minnesota

4. Cleveland Clinic, Ohio

5. Ronald Reagan University of California–Los Angeles Medical Center

6. Northwestern Memorial Hospital, Chicago, Illinois

7. New York–Presbyterian University Hospital of Columbia and Cornell, New York City

8. University of California–San Francisco Medical Center

9. Brigham and Women’s Hospital, Boston

10. UMPC-University of Pittsburgh Medical Center, Pennsylvania

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Johns Hopkins Hospital,Baltimore,Maryland – rated top in the US despite its ordinary facade.

Its interesting to note from the above list that Johns Hopkins was displaced from its top spot only once – last year in 2012 – when it went to the current runner-up. All the top five have consistently retained their top five status.

The magazine awards points to hospitals based on the individual specialty rankings. In 12 of the 16 specialties, measurable performance in terms of quality of care, safety, and mortality accounts for two thirds of a hospital’s score. The institution’s reputation among specialists, ascertained by a survey, accounts for the remaining one third.

You can read more, including the best hospitals for each specialty here.

So what does it take to be a world-class hospital? Apart from good outcomes, the following are also important:

1. Innovation – A desire to practice in an environment that embraces evidence attracts nurses and other staff to these hospitals.

2. ‘Patient-first’ philosophy – a no-brainer really, but quite easily forgotten by hospitals who pay too much attention to the financial bottom-line. They often forget that its the patients (read ‘customers’) who are paying their salaries!

3. Collaboration – Teamwork creates better outcomes, and many of these  hospitals have embraced fostering greater collaboration between disciplines. Every discipline brings a special domain of practice, knowledge and skill to create a village of information.

4. Quality Improvement- Structured processes for clinical services allow  staff to define and sustain clinical practice standards and incorporate new findings into practice. Care processes and measures for success can be defined and measured via a balanced scorecard.

5. Quality Nursing Care – Patients come to the hospital expecting the best doctor and often, they will get one for their medical condition to be treated appropriately. What can make the difference is the nursing. When nurses add on compasssion on top of the usual nursing skills, they give that extra edge to that hospital’s reputation.

6. Positive Work Environment – Nurses form a key component in any hospital, and to retain and attract them, the hospital management has to create an environment where people will want to work in. In my experience, a good pay is important but this is not the be all and end all. Other factors come into play like professional satisfaction and empowerment.

7. Continuing Education – one of the factors enhancing point 6. We are looking not at just professional education, but also at  social skills like  complaints management.

8. Staff Engagement – When you engage people closest to the work , you  respect them.They want to know where the organization is going and what the driving value is, and you can demonstrate how their work contributes to that. That includes letting the staff know as and when new staff are brought in as part of succession planning.

In my years as a hospital manager, the above values keep on recurring time after time and quite often, many hospitals do not make it to the top quite simply because the above lessons are not assimilated. Let me reiterate, good clinical outcomes are a must.

 

Vitamin Makers Won’t Want You to Know This

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What with more than 54,000 dietary supplements on the market, sold under 1,000 different brands, vitamin pills and dietary supplements are big business nowadays. But there are some things that consumers need to know..

The Food and Drug Administration (FDA) defines a supplement broadly, as an ingestible product containing a “dietary ingredient,” which may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars and metabolites.That practically means anything from plain old Vitamin C to exotic stuff like L-carnitine.

Faced with so many choices, consumers are hard-pressed to know what are safe products. In some countries like Malaysia, the Drug Control Authority issues licences to those that have met safety standards, including supplements. However, as in the US, the FDA does not need to sanction any of dietary supplements known before 1994. Manufacturers producing supplements after that date need only notify the FDA and produce documents showing the ingredient is “reasonably expected to be safe” — according to the manufacturer’s own assessment.So supplement makers need not undergo the stringent tests expected of prescription drugs.

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More Is Not Always Better – taking more than the daily requirements may be harmful

 

More does not mean better –  Often, people think that if they take more than the recommended dose, they’ll reap even more benefits. This isn’t necessarily so, especially in the case of fat-soluble vitamins like Vits A,D and E.  Taking more than the daily recommended dosages can lead to serious side-effects. Vitamin A poisoning can cause liver failure and permanent brain damage, for instance, and I have seen this in my personal practice.

‘Natural ingredient’ does not mean ‘safe’- I can name a lot of natural ingredients used in supplements that are by no means safe. Case in point – arsenic, mercury. A popular Chinese herb,  Ephedra (ma huang) marketed for weight-loss and athletic performance, has in fact caused high blood pressure and death in users.ephedra

What you see is not what you get just because the label says 2 grams of extract does not mean you’re getting just that. The words ‘blend’ and ‘formula’ are used in marketing products which may not contain exactly the claimed amount. This is especially true in expensive ingredients like chondroitin. When reading labels, focus on the ingredient you want, and make sure it’s listed alone as an ingredient , not followed by the word “blend” or “formula.”

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Read the labels carefully!

Health benefits may be debatable- because supplements do not have to undergo the rigours of a scientific study, some claims cannot be proven and are subject to anecdotal and ‘word of mouth’ evidence. Products that  “curbs appetite to help with weight loss” may be no more than unsafe ‘amphetamine-type’ appetite suppressants with high-fibre additives.

Pills are not a substitute for a balanced diet.- In fact, with a balanced diet, supplements are often unnecessary, except if one is recovering from an illness or have special needs. All the supplements one takes is not going to supply the calories and proteins the body needs for its daily tasks.

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So-called herbal formulas actually may contain prescription drugs, like this one which has a Viagra-like substance added.

Some ‘effective’ supplements may contain prescription drugs- supplement makers have been known to add in proven drugs to make their products effective. A classic example are supplements to enhance male sexual performance that have been found to contain sildenafil citrate, an active component of Viagra. See my posting  on “Viagra Coffee – Keeps You Up All Night”.  Tip: don’t buy from an Internet company you’ve never heard of, or one that  only has a P.O. box.

Let your Doctor know- ..what you’re taking, especially when you are scheduled for surgery. Quite a few of supplements like Evening Primrose Oil (EPO) and Gingko interfere with the clotting mechanisms of the blood in conjunction with surgery and can cause excessive bleeding. Its surprising how very few makers insert this warning message on their labels. I have written in an earlier posting here on the list of supplements which can interfere with surgery.

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