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Investigation by Carolyn Skelton. Negative side effects of isotretinoin In my research of the acne last resort drug, isotretinoin, I came across a couple of issues related to the impact of Big Pharma, Pharmac, and potential impacts of the TPP. I began my investigation of the last resort acne drug isotretinoin, because of evidence of the devastating impact it has had on the lives of some young people. A significant number of women in the US gave birth to deformed babies after using the medicine, in the early days of its use before side effects became obvious. There have also been ongoing allegations, accompanied by personal testimonies of isotretinoin users and people close to them. These include young people, like Olly and Jessie who experienced depression and committed suicide after taking isotretinoin. Other Posts in this Investigative Series:Costs of medicines to rise under TPP? In researching isotretinoin I have come across issues related to patent laws, and the ability of Pharmac to make it possible for many important drugs to be affordable for most Kiwis. John Key has admitted that the cost of some medicines in NZ will rise under the TPP, but he and Tim Groser are trying to play down the extent of this. See John Key’s reply to question from Andrew little in Question Time yesterday; and the Transcript of Tim Groser on TV3’s The Nation last weekend TPP, drug regulation, drug trials & profit motive They also claim that the TPP will not stop Pharmac from being able to regulate use of medicines. However, with rising costs, and the potential for pharmaceutical multinational companies to contest Pharmac decisions, there are causes for concern about the extent that Pharmac will be able to regulate the use of prescription drugs. The importance on strong regulation of the acne drug was the focus of part III of my series on isotretinoin. Many people in the US unnecessarily suffered adverse side effects of isotretinoin, because Roche Pharmaceuticals rushed to market this drug (brand name Accutane) as a magical cure for acne in order to maximise profits. In the early days of prescribing isotertinoin in the US, many women using it gave birth to children with awful defects. This was covered in part II of my series. Further campaigning is still continuing against the over-use of the drug which can potentially cause depression, psychiatric disturbances, suicidal thoughts, sexual dysfunction and more. It is also relevant that another other drug developed by Roche to combat flu (Tamiflu), was bought up big in many countries. It has turned out not to be the wonder drug as marketed by Roche. Today’s UK Independent article refers to this as an example of the way research evidence is suppressed by drug developers: A campaigning organisation Alltrials is now calling for the results of all drug trials to be made public. They argue that drug companies and academic researchers tend to suppress evidence of adverse reactions to trialed medicines. This week they highlighted news articles about an investors’ group calling for more information about the activities of pharmaceutical companies they invest in: This suppression of research evidence is contrary to the claims of Big Pharma wanting more transparency around Pharmac decisions. See Gordon Campbell on this and other issues with respect to the TPP and Pharmac here; and here. TPP & potential for drug multinationals to dispute NZ decisions More information from Pharmac could make it easier for multinational drug companies to challenge decisions of national agencies like Pharmac. Tim Groser has tried to damp down claims that this will happen with Investor State Dispute Settlements under TPP, as argued here in the Guardian: Key and Groser claim it is no different from other trade deals with China and South Korea in enabling corporates to sue decisions by the likes of Pharmac, and that it hasn’t yet happened. However, these countries are not crucial ones for developing new drugs. The big pharmaceutical corporates are largely based in the US, and to a lesser extent in Europe. And it is these companies that will get more power under the TPP. While Big Pharma can do research that produces some very useful medicines, the good they do can be undermined by the profit motive. National pharmaceutical agencies like Pharmac, need to be able to operate objectively, in the interest of potential drug users, without being pressured by corporate entities. TPP, Pharmac, generics & patent laws The government updated NZ’s Patent Law in 2013, but it looks like the TPP will conflict with some aspects of it requiring the Act to be amended, as suggested by Jack Redfern and Gareth Dixon in August 2014. This possibility is reinforced by John Key’s statement today that the costs of medicines will rise under the TPP, when previously he had denied this would be the case. Curiously, the government did not make changes to the patent law as requested by NZ-based affiliates of multinational pharmaceutical companies (including Roche that initially developed the acne drug) in their 2009 submission to the proposed changes to the 1953 Patent Act. This was, with respect to extensions of patent periods, to Pharmac’s single supplier, price-referencing approach, and to its tendency to wait out patent periods til they can access cheaper generics. The drug companies’ claim was that Pharmac’s processes were undermining the price of drugs internationally, driving down the profits such companies would get. The multinational affiliates claim in their submission, that there are not big financial profits in developing new drugs. Interestingly, they are critical of Pharmac prioritising protection of the public against the potential social costs of patents, at the expense of “property rights” [of patent owners]. They claim the latter should be the main focus of patent laws After Roche’s patent for isotretinoin lapsed, and its marketing of it became suspect, US agencies were less inclined to buy their brand of the drug Accutane. This is where a small NZ pharmaceutical company Douglas Pharmaceuticals, benefited from their generic version of the drug. They became Pharmac’s supplier for the medicine and then were able to sell it in the US. By the time this happened, Pharmac and other medical agencies, concerned with users’ safety, were well aware of the potential side effects, issuing strong warnings. Pharmac is about to move away from Douglas Pharmaceuticals as supplier of istoretinoin. An international corporate that specialises in producing generic medicines, will be Pharmac’s chosen supplier as from later this year. The reason probably is because this company’s NZ branch, Mylan (NZ) can supply the drug (brand name Isotane) more cheaply. Mylan’s CEO has come out against the TPP Itsourfuture reports:
The [TPP leaked] draft would make linkage mandatory, as it is in the US, allowing drug companies to fend off generics by claiming patent infringements, the website reported. It cited Heather Bresch, chief executive of generic drug maker Mylan, as saying mandatory patent linkage would amount to “a recipe for indefinite evergreening of pharmaceutical monopolies.”See also here. [caption id="attachment_5819" align="alignleft" width="300"] Heather Bresch. Photographer Jeff Swensen for The New York Times[/caption] The New York Times reports,
Bresch has said that “ the current deal was a way for the brand-name drug industry to “maximize its monopolies.”However, this still means that, under TPP, overseas-based companies like Mylan could challenge NZ authorities and laws (eg to make the patent period longer here), while NZ companies like Douglas Pharmaceuticals could not.