Side Effects - both Pharmaceutical and Economic!

It is generally well understood that all medicines have side effects. Most side effects are unwanted but occasionally some are beneficial enough to encourage alternative use to be made of the drug, indeed to open up new marketing opportunities for the drug company that brought the drug to market and holds the patent.

While working at GSK  I was made aware that this was the background to an anti smoking drug which had been developed initially as an anti depressant. Users of GSK's anti-depression medication Wellbutrin (bupropion hydrochloride) often reported a lessening in the desire for cigarettes. Having been alerted to this consumer feedback GSK undertook further testing and the drug was found to be effective in treating smoking addiction, and helping smokers quit. GlaxoSmithKline "repackaged" Wellbutrin and marketed it as the smoking-cessation drug Zyban.

Pfizer had a similar unexpected huge hit when Phase 1 trials for a drug (Sildenafil ) developed to treat high blood presure and angina was found to have had little effect on angina, but could induce significant penile erection. Pfizer decided to market the drug for erectile dysfunction under the name Viagra

A similar attempt to treat high blood pressure - Minoxidil - has also found to have (short term) beneficial side effects as well as toxic ones. Minoxidil was first prescribed and used as an oral tablet to treat high blood pressure (it still is especially with persistent hypertension that cannot be controlled satisfactorily on other combined therapies). It was during its initial use that hair growth was noticed as a side-effect.

Not missing an opportunity, UpJohn explored developing it as a solution to hair loss and marketed a 2 percent topical solution in the mid 1980s called Rogaine. Since then, UpJohn has developed a 5 percent solution (extra strength Rogaine) and Rogaine for Women.

Topical forms of Minoxidil have moved from being a prescription only product to being available for over the counter sales. Since the 1990s, numerous generic forms of minoxidil have became available to treat hair loss.The oral form is still used to treat high blood pressure and ONLY high blood pressure in the US.  In the UK, Minoxidil for hair growth is not available other than over the counter or on line and then only with with a private prescription. The oral form, now out of patent, is still prescribed for persistent hyper tension but is produced by only one manufacturer (Pfizer).

I was prescribed minoxidil - in the past - and for many years indeed noticed the effect on hair growth. When I stopped taking Minoxidil the male pattern baldness that had been on hold reappeared.

I suffered for a  number of years ( about 4) with post operative infection, during which time the minoxidil was stopped and my blood pressure controlled with a combination of other drugs. The post operative infection  required  a 2 stage hip replacement leaving me with a few inches of femur and loss of about a cereal bowl's worth of thigh muscle. In time the renal clinic I attended began to notice that the blood pressure was again slowly getting out of control. Initial additions to the drug regimen and increases in strength failed to control it to the extent required and it was suggested that the systemic infection had exercised a vaso dilating effect which had the interesting and "beneficial" side effect of lowering my blood pressure). Successful cessation of the underlying (post operative) infection meant that a similar vaso dilating effect might be required through medication - like minoxidil - to regain control.

So 1 month ago I was restarted on minoxidil oral 5mg daily. My blood pressure returned to the levels that the renal clinic are content with and I tried to obtain a repeat prescription through the local pharmacy.

In the past the local pharmacy had experienced difficulties obtaining supplies and I needed to switch to a more central pharmacy that - most of the time - manged to secure an adequate supply.

I did not want to have to transfer "loyalty" again so hoped that the previous problems had been sorted out in the meantime ....... They may well have been ..... but to my surprise not only can the local pharmacy not get any until late September but the main central community pharmacy cannot either - saying that there is a manufacturing problem!

I emailed the consultant who prescribed the medication and sent a copy to the Pharmacist employed by the PCT to manage and plan community pharmacy services for the city in case this was symptomatic of a more general problem. In his response he pointed to a general problem with a number of branded medicines caused partly by the effective devaluation of Sterling and the European Community free market which removes any barriers to free trade within the community. It is therefore not in the interests of manufacturers to do anything other than maximise profits and satisfying those who pay most. One "side effect" of this is that they have imposed quota's on those customers ( such as the NHS) who are not prepared to pay most.

The previous government held talks before the election this year to try to attend to this unintended consequence of "world class commissioning" in primary care and the current coalition are also planning to respond. The problem is indeed more widespread than minoxidil and it appears that the current work around is to contact manufacturer's direct and I guess plea for special treatment. The notes of the discussions in Spring 2010 about
Branded Medicine Shortages can be read by clicking on the link to the left.

So we really are "all in this together" - and unless the NHS is ready to compete with other customers of big pharma, some patients may well be denied medication they require as an unintended consequence (side effect even!) of current economic woes and pursuit of "world class commissioning". In my case I have obtained a further month's supply becasue the hospital consultant has agreed to issue a prescription that the hospital pharmacy will fulfill. I'm not sure this represents a lomger term remedy but am grateful for small mercies.

In these days of separate budgets (even though all funded by public taxation) I am grateful that the accountants and managers remain ignorant as I 'm sure they would not allow this "cost shifting" to take place.  I hope no-one on minoxidil is denied further supplies and suffers a stroke or other avoidable incident.

I wonder what jobbing doctors (and Jobbing Doctor in particular) make of this. I'm sure it would be enough to make Dr Grumble and others pause for reflection.