Tag Archives: FDA

For Real or Just Hype?

Reading the media, many doctors are fascinated as to the plethora of new drugs claiming to provide a ‘cure’ against diseases which hitherto were considered incurable. Why, new drugs have even pervaded the social media – pharma companies have started posting widgets on Facebook in a bid to attract readers. Last month, FDA cautioned the drug company Novartis for overstating the benefits of a drug without pointing out the ill-effects (see here).

Social Media as a Marketing Tool - even Big Pharmas Use It

 

 

This rampant form of advertising naturally may confuse the public about the efficacy of new medications. In fact, its sometimes difficult to know the validity of claims made in the media.

Here are  some tips on how to evaluate the validity of medical news items that you may come across..

  • It is a fact that competition is intense among medical journals, research bodies and medical journals to attract media attention. Media themselves compete with each other to come out with the latest. Try to read the same news from several sources. Obviously, if the item is reported in just one obscure source, it should carry less weight.
  • Look for key-words like suggestive or may (as opposed to will) as this does not always indicate a cause and effect meaning. Many people make hard-core assumptions based on such words.
  • It is the nature of scientific studies that, for a given topic, several would say one thing and a few would say the complete opposite. It is for the trained professional and their peer-groups to make an informed decision to advise consumers. Bear in mind that space is a premium with the mass media and such reports usually omit vital details which will affect accuracy.
  • Separate the wheat from the chaff..make sure the website you’re looking at is a reliable one!
  • Personally, I feel reports originating from researchers and pharma companies should not appear in the mass media without vetting by an appropriate professional body so as to convey the proper perspective to the audience at large. So if a news report originates from a known professional body, this should carry a lot of weight; as opposed to a solitary item in a nondescript health magazine.

Your Sugar or Your Heart?

Those familiar with the ongoing debate whether to ban a popular anti-diabetes drug for potentially dangerous side-effects are mostly wondering why its taking the authorities so long to put a ban on it.

Glaxo’s Avandia, also known as roziglitazone, has been blamed by research studies as far back as 2007 to cause heart problems when taken by diabetic patients, but attempts to ban it have been painfully slow. While the FDA acknowledged that the drug led to a higher incidence of heart attacks since 2007,  its advisory panel in July this year stopped short of banning it with a split decision.

Avandia ban - decision to be made by EU September

Health advocates have mounted a strong campaign against Avandia, saying its risks outweigh its benefit. Even a conspiracy theory has emerged – the New York Times this week published documents that it said showed SmithKlineBeecham – the firm’s name in 1999 – buried a disastrous study that suggested Avandia posed greater heart risks than a competing drug. Has Big Pharma managed to buy out the regulators?

Across the Atlantic, the story is clearer – the UK watchdog authority has called today for the withdrawal of this drug across Europe.(here).

And the irony of it all..while we have a diabetic drug that can cause heart attacks, we also have a heart  drug (Crestor) that can cause diabetes!

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And Now..Cholesterol Pills for those with Normal Cholesterol!

In a decision which raised the eyebrow of many doctors as well as patients, a popular cholesterol pill Crestor (rosuvastatin) has now been approved by the US FDA for use in healthy people with normal cholesterol…well, not just anybody, but for those with all of the following 3 features: increasing age + high CRP + one traditional risk factor (either smoking, high blood pressure, positive family history, low HDL-cholesterol).

At US$2 a pill, its wider usage can mean big bucks for big pharmas

In a recent bulletin, the FDA took pains to say that this was based on a clinical study (the Jupiter Trial) which showed that those who took Crestor for two years experienced less heart attacks, strokes and needed fewer heart operations.

Even so, a few cardiologists, including yours truly, have some trepidation in unreservedly recommending Crestor for such people with normal cholesterol. In the first place, no amount of medication is going to substitute for adopting a healthy lifestyle (in other words, regular exercise,proper dieting, weight reduction and getting rid of the fags). Both need to go hand in hand in order to achieve any benefit.

Erectile dysfuction -a real problem with drugs like Crestor

The other downside in taking these pills is the risk of side-effects, most notably generalised muscle and joint pains and..listen up, you men..poor erection! Yes, many patients feel shy to bring this up with their doctor but it seems to be more common than reported. The good thing about this problem is that its “business as usual” once the pills are withdrawn. Recently, news reports have even implied that statins (like Crestor) can lead to diabetes.

There are many who suspect that promoting this use of  Crestor is big pharma’s way of enhancing sales in these troubled times..not to mention giving private insurance companies a valid reason for raising your premiums because you’re on medications.

The issue sure is getting more complicated nowadays; with a diabetes drug supposed to cause heart attacks (Avandia) and conversely, a heart attack drug that may cause  diabetes (Crestor) !! If its any indication, 4 of the 12 members in the FDA Drug Committee objected to this new indication for its use..

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Pandemic, Panic and Profits

Where there’s a pandemic, there’s profits to be made..and even the most reputable of companies will fall prey to their marketing strategists in order to boost the financial bottom-line. Take the case of the well-known pillar of health foods – Kellogg’s.

Kelloggs

Take a closer look at the bottom half of the package and you can sniff the marketing overhype, especially as the world is facing the resurgence of the H1N1 pandemic. Not only is the claim misleading but the timing bad, especially when the H1N1-conscious public is grappling with the shortage of flu vaccines. Some city councils have sent letters to the US FDA asking Kellogg’s to back its claim.(The FDA has jurisdiction over false or misleading labeling. FDA officials are not permitted to discuss specific cases under consideration and declined to comment on this one.)

I’ve written in an earlier posting Pandemic,Panic and Profits”,  about the way some multinationals are using  herd psychology in these troubled times to imply, by soft association, the link between H1N1 infection and various remedies. But this one takes the cake..the FDA may have the last word yet..

Update 6 Nov 2009: Kellogg Co just announced that they will pull out the immunity claims from all their cereal boxes. See here.

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Smoking… Where There’s A Threat, There’s Opportunity

As more and more countries join on the bandwagon to plaster graphic pics on cigarette packets in an attempt to reduce the numbers of smokers, some are questioning whether such measures are indeed successful. Well, there’s no need to go further..take a look at these figures from the United States’ CDC:

smoking_graph

Its taken the Americans 40 years to reduce by half the number of smokers..and this in spite of the introduction of one of the nation’s strictest bans on smoking in public places by the state producing the most tobacco in the US –  North Carolina.

smoking_advert

Tobacco companies exert their presence on Kimi Raikonen & John Todd at the Bahrein F1 Grand Prix,2007

smoking_electronic

Another Innovative Product - No Smoke But Still With Nicotine!

Some blame the slow reduction in the number of smokers to tobacco companies’ subtle strategies in fighting for their cause – sports sponsorship,adverts targeting teens and the like – but the real cause in the US is that Federal Agencies and public health advocates cannot regulate tobacco use, just like it can for drugs and breakfast cereals.

But this will not be for long..the US Senate will debate over the next few weeks giving the Food and Drug Administration (FDA) authority to regulate tobacco products. Some points include:

• The FDA needs to approve claims of “reduced harm” by the industry, which is already introducing a new generation of supposedly less dangerous products.

• Ingredients in tobacco products need to be revealed to the government — a big improvement over the current situation, where the public is in the dark.

• The FDA will mandate larger warning labels, curtail marketing to children, and ban the use of labels such as “light” and “mild.”

Tobacco companies, which have mastered the art of marketing deception into a fine art, will probably snigger a bit as they know the FDA is already overloaded with work ,and such new regulations aren’t going to lessen the burden. However, word has it that the extra costs needed to regulate smoking will be passed back to the tobacco industry!

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Health Alert (8): Pain-Killers That Can Kill

Weeks after reading in the local papers about a 7 year-old boy that died after taking paracetamol (aka Panadol aka acetaminophen aka Tylenol) for fever at an adult dosage of 4000mg per day, my attention was directed to the coincidental release about this drug by the US Food & Drug  Administration. The FDA have now issued warning guidelines on the use of this popular pain-killer, generally regarded as one of the safest around and sold everywhere over-the-counter, without the need for a doctor’s prescription.

panadol2

The most popular brand of paracetamol worldwide

panadol-tylenol

..popular in the United States

The news release requires that the labeling must warn of the risks of stomach bleeding in alcohol-users and severe liver damage from overdosage. The latter has been blamed for many deaths arising from overuse of this drug.

The report also calls for limiting the maximum adult daily dose to no more than 3,250 milligrams (one paracetamol tablet is usually 500 milligrams, so that means the current recommended dosage of up to 4000 milligrams is already too high), but with a lower daily maximum for patients consuming three or more alcoholic drinks every day. For kids, all liquid forms (syrups) need to be in a single medium strength formulation with much lower dose recommendations.

My take on this is that every drug you take can have side-effects – its a question of balancing the pros and cons and,of course, taking it correctly!

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Health Alert(6): More Weight-Loss Pills Banned

The U.S. Food and Drug Administration is alerting consumers not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.

weight-loss-lies

Impressive weight-loss ads such as this detract the consumer from the dangers of using some slimming drugs

Included among the list are quite well-known ‘slimming pills’ and ‘slimming drinks’ marketed on the Internet as ‘dietary supplements’ or containing ‘natural’ or ‘herbal’  supplements. FDA said some of these products also contained sibutramine (a controlled substance),  phenytoin (an anti-seizure medication), phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent) and rimonabant (a drug not approved for marketing in the United States).

The last-mentioned drug was highlighted in my last post on health alert here. Marketed in many countries in the Far East as Accomplia, it was withdrawn by the European Union in October 2008 because of the high incidence of depression and suicides amongst users.

For a full list of the drugs affected by the ban, go to the FDA News.

Health Alert(1): FDA issues warning on CT scans for patients with pacemakers

The Food and Drug Administration(FDA) is warning doctors and patients that electronic devices such as pacemakers, cardiac defibrillators and insulin pumps can malfunction when people get computerized tomography (CT) scans.

The popular scans can cause medical devices to shock patients or start sending inaccurate signals, the FDA said in a public health alert issued 14 July 2008.
It has received six confirmed reports of devices that malfunctioned after a CT scan and another nine reports of suspected problems, FDA spokeswoman Karen Riley said. No deaths occurred.

This untoward effect has not been generally well-known amongst doctors, unlike the widely-recognised rule of not allowing  patients with pacemakers to undergo MRI scans.

CT scans have been known for their high radiation effects, with reports ranging about 500-600 times a normal chest-ray for each CT scan procedure (see my earlier post here)

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