There is a reason drug safety experts recommend waiting five years before taking a new prescription drug. Before new drugs are released to the public, they are tested on a shockingly small group of people for a shockingly short period of time. Risks and safety problems, therefore, often don’t emerge until millions try the drug as we saw with the withdrawn drugs Vioxx, Bextra, Baycol, Trovan, Meridia, Seldane, Hismanal, Darvon, Raxar, Redux and at least 11 others.
Thanks to changes at the FDA, risks presented by new prescription drugs are heightening. Drugs that once would have been rejected by regulators due to their alarming safety profiles are now rushed through, like the blood thinner Pradaxa—already linked to more than 542 bleeding deaths. Drug approvals are also, increasingly, expedited or “fast-tracked”—like Vioxx, which “received a six-month priority review,” admitted the FDA, and went on to cause 140,000 heart events. Merck’s bone drug Fosamax was approved in just six months and was soon linked to esophageal cancer and deaths in medical journals.
Finally, the new FDA commissioner, Robert Califf, has received money from 23 drug companies, including giants like Johnson & Johnson, Lilly, Merck, Schering Plough and GSK, according to a disclosure statement on the website of Duke Clinical Research Institute, erasing any semblance of a government/industry firewall.
Now comes news that the high-priced hepatitis C drugs, rolled out a few years ago with great fanfare, may have been rushed to market before serious risks were identified.
These drugs cost what?
When Gilead Sciences released its hepatitis C drug, Sovaldi, a few years ago, followed by similar drugs from other companies, the medical and insurance industries were shocked—as were lawmakers and public health officials. A single pill was priced at approximately $1,000, which translated into $84,000 for a course of treatment. In addition to the unprecedented prices, the new “Hep C” drug rollouts were accompanied by aggressive screening campaigns to increase the user pool. Even if you have no symptoms or worries you might silently be at risk and need these drugs, said the Pharma messaging, often called “disease mongering” because it employs fear of diseases to grow customers.
Pharma companies initially tried to cast the outrageous prices as recouping research and development costs but quickly admitted they were simply pricing the drugs on “value”—what a Hep C cure was “worth” in the medical system, also known as “what they could get.”
Even mainstream business reporters smelled a rat. Why does the same hepatitis C drug that costs $84,000 a year in the U.S. cost $900 a year in Egypt, asked Avik Roy, who writes for Forbes. “Hepatitis C patients in the U.S. are mostly uninsured, underinsured and/or incarcerated. Medicaid, the VA and our prison system bear the brunt of the cost impact, and by extension so do all of us as taxpayers,” wrote Roy.
Roy is right. Taxpayer-supported, state-run Medicaid programs are being depleted by the Hep C drug profiteering with 33 states having already given more than $1 billion to Gilead Sciences for Sovaldi, reports National Public Radio. Ka-ching.
Lawmakers are taking notice of the apparent price gouging with both the Senate’s Special Committee on Aging and Finance Committee investigating.
Possible risks with Hep C drugs not seen before approval
Certainly, hepatitis C is serious and potentially deadly, leading to chronic liver disease and even liver cancer and cirrhosis. It takes the lives of 20,000 people in the U.S. a year and is the leading cause of liver transplants in this country. But according to a new Institute for Safe Medication Practices report, unintended liver effects may also be occurring with the drugs. In one year, between June 2015 and June 2016, 165 people who took Sovaldi or Harvoni (a competing drug) worldwide died, 524 had liver failure and 1,058 had severe liver injury. It is not yet clear if the drugs were the cause, say researchers.
This is not the first safety signal regulators have received about the new Hep C drugs, which include AbbVie’s Viekra Pak, Bristol-Myers Squibb’s Daklinza and five others. Last fall, the FDA found that 24 patients with pre-existing, dormant hepatitis B infections experienced reactivation of the infections while taking the Hep C drugs. Two patients died and one required a liver transplant. The FDA promptly added boxed warnings on the Hep C drug labels about the possible reactivation of hepatitis B infections. The warnings also direct health professionals to screen and monitor patients accordingly.
Thomas J. Moore, a senior scientist at the Institute for Safe Medication Practices and an author of the new report about possible safety signals with Hep C drugs, has asked what many are thinking: Does the rush to bring a new drug treatment to market come at an unforeseen cost to patient safety?
Warning creep
While it is certainly true that the complete safety profiles of prescription drugs cannot be established before millions of patients use them, it is also true that both Pharma and the government often only acknowledge emerging risks when the drugs have gone off patent and all profit has been taken. The continual addition of new risks and warnings on drug labels after a drug has been approved (and often under the public radar) is sometimes referred to as “warning creep.” Warning creep is apparent with the popular drug classes statins, GERD medicines (called PPIs) and antidepressants in which disturbing side effects were acknowledged years after the drugs had been aggressively marketed and were in wide use.
In some cases, warning creep risks were clearly known to the drug maker and the drug marketer anyway, like the “jawbone death” side effect that Merck scientists knew was linked to Fosamax-like drugs as early as 1977. Research published by the British Medical Journal (BMJ) in 2015 confirms that long suspected suicidal side effects associated with the GSK antidepressant Paxil were known, downplayed and buried by GSK operatives.
Other times, the warning creep risks are the exact conditions for which the drug is prescribed! Paxil sometimes induces the suicides it is prescribed to prevent, and hormone replacement therapy marketed to help women appear “young” was actually linked to hearing loss, gall bladder disease, dementia, urinary incontinence and more. Thanks for nothing. Bone drugs like Fosamax are linked to (in addition to esophageal cancer and jaw bone death) well-documented cases of bone fractures, which they are prescribed to prevent.
And then there’s Humira. Almost 10 years ago, AlterNet reported on serious side effects and questionable marketing behind the blockbuster drug Humira. Humira maker Abbott lobbied Congress successfully in 2003 to get Humira’s $15,000-a-year costs covered by Medicare by seeding seniors with freebies to whet “demand.” Humira and other “biologic” drugs, liquids that have to be injected into a patient, have been a new profit center for Pharma since blockbusters like Lipitor, Nexium, Seroquel, Viagra, Concerta, Seroquel and Zoloft have gone off patent.
Yet biologic drugs like Humira, many genetically engineered and suppressing the immune system, are far from safe. By suppressing the body’s tumor necrosis factor (TNF) they invite tuberculosis, serious, possibly lethal infections, melanoma, lymphoma and unusual cancers in children and teenagers. As early as 2008, the FDA announced 45 people on Humira and related drugs died from fungal diseases and investigated Humira for 30 reports of childhood cancers. Nevertheless, the drug has been so lucrative, it allowed parent company Abbott to spin off an entire new company, AbbVie, primarily to market Humira.
Humira clinical trials revealed allergic reactions, serious hematologic events, aplastic anemia, bone marrow conditions and more, but the drug sailed through its FDA approval. Worse, AbbVie’s patient guide warns that a side effect of the drug is similar to one of the conditions for which it is prescribed: Humira is supposed to “reduce the signs and symptoms” of “psoriatic arthritis (PsA) in adults,” but patients who take the drug may sustain “new psoriasis or worsening of psoriasis they already had.” What?
When so many safety risks emerge with expensive new prescription drugs after approval—even causing the conditions they are supposed to prevent—there is something seriously wrong with U.S. drug regulation and its march-to-Wall Street speedy approvals.
Martha Rosenberg is a nationally recognized investigative health reporter whose food and drug expose, “Born with a Junk Food Deficiency,” won an American Society of Journalists and Authors honorable mention. Rosenberg has appeared on CSPAN, National Public Radio and lectured at the medical school and university levels.
