Look at Pharma’s Recent Record Before Bestowing a Crown

The vaccine “halo” that drug makers are currently wearing obscures their track record of selling addictive drugs, overpriced drugs and drugs with dangerous side effects hidden from the public.

Lest drug makers become Covid heroes let us remember:

* Opioid makers deliberately created the opioid addiction epidemic for profit, assuring patients and clinicians the narcotics weren’t “addictive.” In 2020, OxyContin maker Purdue Pharma agreed to plead guilty to a three-count felony charge which included a criminal fine of $3.544 billion and $2 billion in criminal forfeiture.

* Drug makers priced hepatitis C drugs so high, Congress investigated. Many with the infection are poor, on Medicaid and in prison and two years after release of the drugs, Gilead had netted more than $1 billion from already strained state budgets. The hepatitis C drugs Sovaldi made Gilead $10.28 billion in 2014 and the follow-up drug Harvoni $13.86 billion in 2015. “If Gilead’s approach is the future of how blockbuster drugs are launched in America, it’s going to cost billions and billions of dollars to treat just a fraction of patients in America,” said Senator Ron Wyden, a Democrat from Oregon.

* The lucrative hepatitis C drugs were marketed before their reactivation of hepatitis B was acknowledged and the public was warned. Only after the FDA reported 24 ill patients –– two dying and one needing a liver transplant –– was a boxed warning added.

* Despite the contribution of long acting beta agonist (LABA) asthma drugs to as many 14,000 deaths according to an FDA researcher, label warnings were reversed in 2018 and industry influence was apparent. The SMART trial, a post-marketing LABA safety study, was terminated in 2003 after 16 deaths, 44 intubations, and 369 hospitalizations, mostly in African-Americans.

* In 2020, the FDA added a boxed warning to the leukotriene receptor antagonist asthma/allergy drug montelukast, after impassioned hearings and years of reported mental health side effects and suicides. According to the FDA, “the benefits of montelukast may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with other medicines. For allergic rhinitis, also known as hay fever, we have determined that montelukast should be reserved for those who are not treated effectively with or cannot tolerate other allergy medicines. For patients with asthma, we recommend that health care professionals consider the benefits and risks of mental health side effects before prescribing montelukast.”

* The sexual side effects of the popular baldness drug finasteride ––impotence, lack of sexual desire, depression and a reduction in the size of penises or testicles –– were consistently termed temporary by its manufacturer Merck. Yet confidential court documents revealed that the drug maker had hidden the fact that the effects were lasting to protect sales.

* Best selling biologic medicines for arthritis and psoriasis have been linked to thousand of deaths. Humira has been linked to 13,000 reports of deaths, Enbrel to 8,000 and Remicade to 6,000 according to the Milwaukee Journal Sentinel. The drugs, consistent top sellers and Wall Street pleasers, were also correlated with depression and suicide said the Journal Sentinel.

* After the carcinogen N-Nitrosodimethylamine (NDMA) was found in lots of the H2 histamine receptor antagonist drug ranitidine or Zantac, the FDA requested that manufacturers withdraw all preparations with the drug. During the same time period NDMA was found in metformin, a popular generic prescription drug used to control high blood sugar in patients with type 2 diabetes.

* In 2020, congenital fetal malformations were identified with the stimulant drugs modafinil and armodafinil, marketed as Provigil and Nuvigil. Thirteen percent of 102 prospective live births in the U.S. Provigil/Nuvigil Pregnancy Registry had major congenital malformations according to published reports.

* Fetal risks after 20 weeks of pregnancy were also recently identified with NSAIDS –– drugs like aspirin, ibuprofen, naproxen, diclofenac and celecoxib according to the FDA. The drugs could lead to kidney problems in an unborn baby risking low levels of amniotic fluid said the agency. The FDA also warned that NSAIDs could cause heart issues in a fetus and said that NSAIDs should be limited to the lowest dose and duration.

* In 2018, it was reported that SSRI antidepressants can be very difficult to quit (if not “addictive”) because of severe withdrawal effects. Patients have expressed anger that they were not warned by their doctors they could be “parked” on the drugs indefinitely, unable to discontinue.

* The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted against approval of the diet drug lorcaserin, marketed as Belviq, due to neoplasm risks and valvular heart disease but the drug was approved two years later. In 2020 the FDA requested withdrawal of the drug from the market because the “potential risk of cancer outweighs the benefits.” The cancer risks include pancreatic, colorectal and lung.

* The FDA recently added a boxed warning to sleeping preparations called “Z drugs”– Lunesta (eszopiclone), Sonata (zaleplon) and Ambien (zolpidem) –– citing the danger of “sleepwalking, sleep driving, sleep cooking, or taking other medicines” when “not fully awake.”

* Fluoroquinolone antibiotics such as Levaquin, Avelox, Noroxin and Floxin have received many side effect warnings over the years. In 2016, the FDA advised that fluoroquinolones should be only used for “certain uncomplicated infections” because of their “disabling side effects” which could involve the “tendons, muscles, joints, nerves, and central nervous system.” In 2018, the FDA added warnings about “serious low blood sugar levels” and mental health side effects associated with the antibiotics.

While the many appreciate expedited Covid vaccines, other medicines that drug makers have expedited and aggressively marketed have harmed the public. Worse, the fallout has barely been covered in the year of the pandemic.

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

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