Pharma Patients at Risk with New Drugs, Corruption

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Spilled Bottle of Yellow Capsule Pills, representing drug Fraud and off-label marketing abuse

Two reports on the pharmaceutical industry issued recently put the safety of drugs into question, with one questioning whether new drugs are put on the American market too soon (before all the risks are known) and the other noting the global risks of corruption within the drug industry on public health.

Health Risks in New Drugs

A report in The International Journal of Health Services found that there were 27 market withdrawals and black box warnings for every 100 newly issued drugs. Based on this statistic, the report questioned the propriety of faster market approvals of new drugs by the FDA. It suggests that more time needs to be taken studying these medications to ensure that the health risks are fully understood.

During the 18 year period studied, the researchers found nine drugs were prescribed more than 1 million times before they were withdrawn from the market. In total, physicians prescribed drugs at 112 million office visits that were later removed from the market.

The implication of this research is that some of the patients were ultimately harmed by taking the medication prescribed to them and approved by the FDA. The Corporate Crime Reporter, in its coverage of the report, stated that there are more than 2 million serious adverse drug reactions every year in the United States, which result in an estimated 100,000 deaths.

In addition to the criticism of the FDA for allowing these products to be put on the market, the report also criticized pharmaceutical industry advertising of the new drugs. By promoting the drugs soon after approval to a wide audience, it may contribute to the health risks by exposing large groups of patients before the consequences of the medication are fully known.

Corruption in the Pharma Industry

Transparency International has also put out a new report about corruption in the pharmaceutical industry. The organization found that pharmaceuticals are “particularly prone to corruption” within the health care sector. Moreover, it found that there continue to be vulnerabilities to corruption throughout the pharmaceutical value chain that contribute to a “breeding ground for corruption”.

Corruption can lead to patient harm through various points in the process, including by weakening regulatory protections that ensure new pharmaceuticals are safe, allowing adulterated (bad / fake) drugs to enter into commerce, or the payment of bribery and kickbacks to physicians.

As whistleblower attorneys, we are familiar with the problem of health care corruption because violations of the Anti-Kickback Statute and the Foreign Corrupt Practices Act can be reported by the False Claims Act and the SEC Whistleblower Program.