SCRUTINY of new drug applications with appropriate testing, where necessary, is important to keeping a society safe from ineffective or harmful drugs and other pharmaceutical products. Some countries have their own pharmaceutical testing agencies, while others depend on those in the United States of America, such as the Food and Drug Administration, to test and make public declarations for them to follow.

Customarily, there are two sources of new drugs wishing to enter the market of a country. Firstly, there are the drugs coming from phase III clinical trials, which have undergone testing first in animals, then in healthy humans, then in those people who are afflicted with the illness or disease the drug is supposed to treat.

Another source of new drugs are generic drugs that are supposed to be duplicates of brand-name drugs already existing in the marketplace, but where patent ownership of the latter by a pharmaceutical company has expired. Copies of such drugs can then be manufactured and made available at a cheaper cost. However, they need to be tested to ensure they reach the same standard of safety and effectiveness as the original branded drug.

TESTING OF NEW DRUGS FOR THE CARIBBEAN

For Jamaica and other member countries of the Caribbean Public Health Agency (CARPHA), testing of such drugs may be done by the CARPHA Drug Testing Laboratory based at Hope Gardens in St Andrew. It forms part of the Caribbean Regulatory System (CRS), which is an initiative of the Caribbean Community (Caricom) and is located as a regulatory unit within Caricom’s regional public health body, CARPHA.

This regulatory system carries out its mandate by registering generic multi-source finished medicine products that meet the specific CRS eligibility criteria, and recommends products reviewed favourably to Caricom member states. It also carries out pharmacovigilance (monitoring the effects of medical drugs after they have been licensed for use) to possibly identify and evaluate any previously unreported adverse reactions.

Such a robust system of evaluating and monitoring pharmaceutical products is crucial to safeguarding the health of the public who use these pharmaceuticals. It also exemplifies how smaller countries, with very limited resources, can work together to effect a regional regulatory system that best protects their own welfare.

FRAUDULENT DRUGS

A recent article in the British Medical Journal (BMJ) informed that just over 80 per cent of clinical trial data submitted to support new drug registrations in China was found to be either fraudulent or substandard by that country’s drug regulator. Of the 1,622 new drugs submitted to China’s State Food and Drug Administration (CFDA) for registration, 1,308 of the applications contained fabricated, flawed, or inadequate data from clinical trials.

Much of the blame was attributed to the country’s loosely regulated clinical research organisations, which some claim operate in “cut-throat” competition and resort to data fraud to gain drug registrations.

This included breach of duty by supervision departments as well as malpractice by pharmaceutical companies, intermediary agents, and medical staff in clinical trial fraud. This fact was discovered after China’s regulatory body assigned 366 staff personnel to verify the details of clinical trial dossiers supplied to support drug registrations. They found discrepancies between original trial data record books and submitted files, and in some cases, a complete lack of raw data. In many instances, data had been fabricated or altered, and for some trial reports there was clear evidence that data had been reported selectively or adverse events data manipulated or hidden.

In one example, the data was declared as suspect by the regulatory investigators because they had apparently been recorded by staff who had not yet started employment. The report listed 10 institutions (including hospitals) with the highest volume of clinical trial submissions and the top 10 clinical research organisations that submitted clinical trial data. One hospital manager reported that much of the fraud could be attributed to competition between China’s numerous generic drug manufacturers who are eager to have their products registered to share in the country’s booming $108-billion drug market.

INDEPENDENT ASSESSMENTS

Many drug companies outsourced clinical trials to contract research organisations that offer a ‘no win, no fee’ service for drug registration applications. The CFDA has consequently intensified the scrutiny of new drug applications with a zero-tolerance approach to clinical trial data fraud.

The CFDA report was said to be the latest development in the Government’s crackdown on corruption in China’s health care and medical research sector. A new policy has therefore been enacted by the National Health and Family Planning Commission in China that requires clinical trials to be run under the auspices of hospital research committees rather than individual doctors or their departments.

Derrick Aarons MD, PhD is a consultant bioethicist/family physician, a specialist in ethical issues in medicine, the life sciences and research, and is the ethicist at the Caribbean Public Health Agency (CARPHA). (The views expressed here are not written on behalf of CARPHA)