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Counterfeit/Substandard Drugs: All the Good that is Being Done can be Undone

August 15, 2012

On March 10, 2005, the World Bank conducted a workshop entitled: “Good Intentions—Bad Drugs”. The keynote speaker from the Bank commented, using WHO data: “in 2004, approximately $30 billion was expended on fake drugs in the same countries where legitimate health expenditures were only $8 billion”.

The WHO reports that an estimated 10% of the global market (valued at over $1 trillion) for medicines is counterfeit. In developing countries the problem is larger, estimated as high as 25-50%.   Another WHO study estimated that 30% of drugs sold in Africa were substandard. In still another study within five African countries and India, 41-47% of drugs sampled did not meet all quality standards.

Some Definitions:

According to WHO, counterfeit drugs are deliberately and fraudulent mislabeled with respect to identity and source. They are produced by criminals.

Substandard drugs are genuine drugs produced by legitimate manufacturers that do not meet the recognized quality and purity standards used by that manufacturer or by the regulatory authorities. By definition, then, copy drugs are substandard drugs.

The problem of counterfeit/substandard medicines has been seething for some time, bringing in their wake an accelerated onset of drug resistance.  In 2004, WHO had to de-list 36 ARVs that it had previously placed on its Prequalification Programme.  All had been produced in India and were substandard drugs, aka as copy drugs, rather than generics. WHO announced in a public statement that the de-listings were due “to a lack of proof of bioequivalency”. However, WHO did not require its Members to recall the drugs or to conduct a post-marketing surveillance, a requirement of stringent regulatory authorities.

In 2007, the Global Fund to Fight HIV/AIDS, TB and Malaria had a Three Option procurement policy. Option C included drugs that were not approved by a regulatory authority even when there is an approved, prequalified alternative. In that year, the Fund documented that of 2,254 single procurements by its recipients, “half were found to be non-compliant with its QA policy and one-fifth were purchased using Option C. The Fund was notified in only 2 of 426 cases.”

WHO was supposed to have guaranteed that such procurements were from countries thathad earned a GMP Certification from the Organization. This is a manufacturing standard rather than a product standard attesting to its quality, safety and efficacy. Other UN-affiliated entities, such as UNITAID and the Clinton Foundation, used Option C also.

On July 1, 2009, the Global Fund approved a revised Quality Assurance Policy for Pharmaceutical Products. It has two options: 1) Prequalified by WHO or authorized for use by a Stringent Drug Regulatory Authority; 2) Recommended for use by an Expert Review Panel (ERP). Subsequently, WHO was designated as the ERP. WHO’s  basic requirement for procurement under the second is GMP—a Certification that it issues to Member States. Of the two Options, then, only part of the first relies on standards recognized by stringent regulatory authorities, such as the FDA and EMEA. Yet, the Fund equates WHO, a Membership Organization, in Option 1 with those same authorities. In all editions of its Prequalification Programme, WHO issues a Disclaimer: “not warranted for safety and or efficacy if used in the treatment of HIV/AIDS.”

The Center for Global Development (CGD) published a landmark study on drug resistance in 2010.

  1. Regrettably, the practices of those who are seeking to expand access can unintentionally accelerate the spread of resistance by making drugs widely available where conditions for assuring quality and appropriate use are weak;
  2. the opportunity costs of treating resistant diseases are considerable. For instance, it costs as much to cure one patient of extensively drug-resistant XDR-TB as it does to cure 200 patients of susceptible TB;
  3. for every person put on 2nd line ARV treatment due to drug resistance, far fewer people can then be given access to life-saving or life-extending care;
  4. about 22% of AIDS patients switch to 2nd line therapy after about 20 months on a lst line therapy;
  5. and, health care experts expect that high mutation rates of the virus mean that eventually all those on ART will acquire resistance to the drugs they take.

On July 13, 2012, The Washington Post printed an article in its editorial page on unsafe drugs. It commented that “some drugs that the World Health Organization has approved for distribution to the world’s poor are of inferior quality—and some of the manufacturers, predominantly Chinese and Indian firms, may be knowingly producing them. … Sometimes a fifth of them failed basic quality-control  tests”.  Although WHO has launched an investigation into product failures, “it lacks the resources to do much more”.

On August 5, 2012, perhaps in response to the global publicity from The Washington Post article, China arrested 2,000 people, and destroyed 1,100 production facilities as part of a nationwide crackdown on counterfeit drugs.

When the CGD article was published in 2010, there were fewer than 4 million patients under ARV treatment. Today, that number has increased to 8+ million.  That report went on to comment: “unfortunately, the global health discourse about extending use of ARVs focuses almost exclusively on treatment targets, neglecting the reality that as more drugs are used, more resistance will be selected for”.

The CEO of U. S. Pharmacopeia publicly warned: “there are likely to be few faster ways to induce resistance to current AIDS drugs than by treating patients with substandard products”.

As treatment targets continue to increase towards universal coverage for HIV/AIDS, TB and malaria patients, it can be expected that counterfeit/substandard drug use will follow suit. And in train, drug resistance will rise globally, imposing substantial health and economic consequences.  During the World Bank seminar in 2005, the Director of its health office commented: “much of the good being done is rapidly being un-done by unscrupulous counterfeiters whose only objective is profit at the expense of the poor”.

What can be done! WHO can undertake a major corrective step in this regard by recognizing its limits as a Membership Organization and refrain from approving drugs, then issuing Disclaimers—which are unknown to patients.  It made such a correction in 2004 after de-listing 36 ARV copy products and then partnering with the US FDA on ARV therapies in its Prequalification Programme. Today, almost all of its listed ARV products now carry a FDA certification as true generics.  WHO can expand its considerable moral powers with other stringent regulatory authorities, such as the EMEA, for other therapies and thus ensure that poor patients in the developing world receive access to drugs of known quality, safety and efficacy—without a Disclaimer.

Now that WHO is supporting a new global program to include access to medicines for chronic diseases, this corrective step is an imperative!

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