By Jefferey Jaxen
A recent Gallup poll revealed the pharmaceutical industry is the most despised industry in America. Very few people are likely surprised.
On a weekly basis one can find national headlines exposing pharmaceutical industry corruption. Readers grow weary of editorials exposing the fraudulent marketing of drugs or medical devices, the manipulation and concealment of vital safety data, or revelations about the role of big pharma in the devastating opioid epidemic.
Despite the industry’s public image, and the myriad lawsuits due to fraud and corruption, these embattled corporations and legislatures are given both social and legal license to market and mandate one of the most controversial products in the history of public health. Why?
Too many still remain unaware the general public cannot take legal action against harm done by the vaccine products of pharmaceutical companies. The National Childhood Vaccine Injury Act of 1986 restricted, but didn’t fully eliminate, product liability for vaccine makers. In 1987, an amendment extended liability protection for pediatricians and other vaccine administrators. Then, the 2011 Bruesewitz v. Wyeth case led the U.S. Supreme Court to block the legal right of vaccine injured persons to hold drug companies liable for design defects and failing to improve FDA licensed vaccines to make them less harmful.
“[T]he majority ruling in this Supreme Court case means that, today, even if a drug company could have improved a government licensed and mandated vaccine to make it less reactive, a vaccine injured person cannot sue the company in a civil court in front of a jury of peers.” writes the National Vaccine Information Center.
Supporters of this liability protection, often the same supporters of mandatory vaccination laws, will say that vaccine-makers and their injectable product lines are vital to public health and the greater good.
But what if we’ve allowed the historically criminal and corrupt pharmaceutical industry too much leeway? Is it enough to hope pharmaceutical corporations, out of pure altruism, decide to act in the best interest of the public, when the most basic and common checks and balances have been removed?
Vaccines are slowly emerging on the year-end balance sheets as one of Big Pharma’s cash cows. Furthermore, the pharmaceutical industry has made no secret their future product lines will be moving towards injectable products increasingly mandated by law. Example: HPV vaccine-maker Merck announced it was investing $1B in Virginia to expand its manufacturing operation and increase production of its Gardasil vaccine line.
Since the public rarely sees rulings on vaccine cases and is shut out from the legal window of discovery from pharmaceutical companies in vaccine matters, we need to look at their behavior in previous cases. Vaccine-makers go to court regularly for the harms their drugs cause. What’s often discovered is that even though the rules are in place to implement safety science and prevent corporate skulduggery, they don’t play by them.
A recent Reuters investigation showed vaccine-maker Merck likely exaggerated the safety record and downplayed the side effects of its popular hair-loss drug Propecia. Discovery documents included a motion filed accusing Merck of underreporting the number of men who experienced sexual problems when on the drug and concealing the duration of those problems once treatment ended. Label changes to Propecia’s insert in 2002 showed what appeared to be manipulation of the science to hide potentially profit-destroying adverse reactions. In a correspondence before the label change, Merck’s senior director of clinical research called the conclusions, which Merck eventually added to their label, “totally misleading.”
A 2008 investigation by Swedish regulators found that sexual side effects continued after treatment was stopped. Merck changed the label in the U.K., Sweden, and Italy, to warn that sexual dysfunction may be permanent. It wasn’t until 2012 when America’s best-selling hair loss drug finally acknowledged reports that a range of sexual problems persisted after men stopped taking the drug, by making changes to its label at the behest of FDA officials.
Similar issues surround revelations from the tidal wave of opioid litigation, thanks in part to legal discovery. Findings show marketing reps targeted high prescribing doctors to use stronger opioids for longer durations, despite no science to back up safety claims.
Even when pharmaceutical companies are taken to court, their inconvenient truths are often shielded by the politics of the current system. There has been a disturbing trend in the judicial system, of judges sealing evidence in cases relevant to public health and safety—denying regulators, doctors, and patients, highly relevant information about drugs and medical devices.
The trend of secrecy was and still is happening in Merck’s Propecia case. But the incorrect filing of discovery documents led to some of it being put in the public record, while another document was incorrectly redacted, allowing Reuters to obtain them both.
As in Merck’s Propecia case, early opioid lawsuits saw similar interference from judges to hide evidence that had the potential to stem the duration and harm caused by opioids.
A West Virginia Circuit Court was the first to hear a lawsuit filed by a state against Purdue Pharma in 2001. Now in bankruptcy for its role in the opioid epidemic, Purdue sent thousands of pages of internal memos and notes from sales calls on doctors, marketing plans, and other records, to the state’s lawyers for the case in 2001.
Yet the judge sealed the evidence and it remained hidden, out of sight of regulators, doctors, and patients, until it was leaked to the LA Times in 2016 and became part of their investigative exposé. By then the epidemic had taken a toll on American citizens, claiming hundreds of thousands of lives.
Vaccine products also get a free pass in their pre-licensure safety testing by not being subjected to the ‘gold standard’ of double-blind, placebo-controlled trials, and often benefit from limited windows of observation for severe adverse events. Many who follow the trends believe that if vaccine-makers were forced into the legal discovery process in court over vaccines, several truths once considered myth would be confirmed as fact.
A current is forming, aimed at overriding the Bruesewitz v. Wyeth Supreme Court decision. Minnesota and Washington lawmakers have taken the initiative in the hopes that other states will join. Minnesota Representative Jeremy Munson said during a press conference: “if everyone believes that vaccines are safe, that they cause no injury, that they can’t cause injury, then there should be no problem with this.” Munson said they are seeking a “resolution asking Congress to act…I want this conversation to happen at the federal level.”
Remember: Doctors and patients who were concerned about the addictive nature and harms of opioids were labeled by the medical community and media as ‘opiophobic,’ a term propagated by the pharmaceutical industry.
It took the correspondences found in just a few legal discovery documents and rulings to forever change that false stigma. How long will it be before those who question the safety of vaccines are allowed to do so without facing unjust discrimination?