Doctors Recommend Treatment that Doesn’t Meet with FDA Approval

FDA approval, biologics, drug safety

New information surfaces about drug safety and the risk of biologic medications administered outside of FDA approval.  A group of prominent dermatologists issued a set of national guidelines for treating psoriasis in 2011.  Nothing unusual, except that their recommendations do not meet with FDA approval.  Furthermore, many of the doctors had financial ties to drug companies.

This is not an isolated incident, but rather part of an overall pattern.  Increasingly, doctors are pushing the use of immune-suppressing biologic medications to treat autoimmune conditions, despite strict warnings from the U.S. Food and Drug Administration (FDA).

Doctors Recommend Treatment Outside FDA Approval

In 2011, a group of prominent dermatologists agreed that a certain class of immune-suppressing drugs could be used to clear up mild skin issues ahead of weddings or other special events.  A problem arose because the group’s recommendation was contrary to the FDA-approved use for these drugs.  The biologic drugs in question carry very strict safety warnings and guidelines from the FDA.

In 2012, the pharmaceutical research and development company AbbVie created a program that paid nurses to make home visits to patients.  Nurses were to assess patients who had a prescription for Humira, a biologic drug used to treat rheumatoid arthritis and psoriasis.

AbbVie instructed the nurses not to mention the risks associated with the drug, though the risks include potentially deadly infections.

In 2014, Pfizer funded a study of its rheumatoid arthritis drug Xeljanz.  The study had 12 expert authors, all with financial ties to Pfizer.  Unsurprisingly, the study found that Xeljanz  was the most effective among its competitors.  The problem in this instance is that the study did not compare Xeljanz to treatments that experts outside of the study considered to be most effective.

Why the underhanded practices? The Journal Sentinel suggests that these three efforts constituted a coordinated effort by drug companies to boost the sale of biologic medications.

Biologics – a $45 Billion Industry

Each of the drugs in the above examples are expensive immune-suppressing drugs designed to treat autoimmune conditions like psoriasis or rheumatoid arthritis.  They are all also biological medications, sometimes called biologics.

First introduced into the pharmaceutical market two decades ago, biologics have reached $45 billion in sales.  Despite their ever-inflating prices and ever-increasing reports of side effects, pharmaceutical companies have funded numerous studies and pushed a massive advertising campaign to keep Americans buying these drugs.

With billions of dollars in sales at stake, the pharmaceutical industry is spending money at every step of the process to keep patients taking biologics.  Companies are increasingly doing the following:

  • Saturating TV commercials and magazine ads that tout the benefits of the medications.
  • Treatment guidelines written by doctors with financial ties to drug companies that call for doctors to prescribe them.
  • Favorable studies funded by drug companies, often conducted by researchers who also consult and represent the drug companies.

What are Biologics?

Biologics are medications created in a laboratory by culturing animal cells.  After stringent purification, medical professionals administer the drugs by injection or IV.  Compared to conventional medicine, biologics are a very effective and do lead to significant improvement in symptoms among many patients.  Some fortunate patients even experience complete remission of autoimmune symptoms.

However, these medications leave patients susceptible to serious side effects.  Furthermore, biologics suppress the immune system and make users more likely to contract life-threatening infections.

Biologics and FDA Approval

There are 20 biologics on the market that have FDA approval.  Sixty-two percent of them must use the agency’s most urgent warning, known as a black box warning.  The FDA issues a black box warning for only the most serious health risks.  For the majority of the biologics that have an FDA black box warning, these warnings were added after the drugs hit the market. This is also after serious risks and side effects began showing up among patients.

According to the FDA’s adverse event reporting database, consumers have reported more than one million adverse events to the agency since 2004.   Almost half of those events were serious.  Around 34,000 of the reported adverse events were deaths associated with the use of biologics.

Skyrocketing Prices Defy Economics

Biologics are some of the biggest sellers in the American pharmaceutical industry.  There were more than six million prescriptions in 2018, which is a massive increase from the four million in 2013.  That’s a 50 percent increase in just five years.

The top-selling biologic drug is Humira, which is useful in treating arthritis, psoriasis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.  There are more than three million patients with active prescriptions for Humira.  Profit margins for this drug have increased 150 percent since 2013.  Humira is on pace to earn $18 billion alone, which is 40 percent of the market share in a single product.

Biologic drugs are also exceedingly expensive.  The list price on some biologic medicines can top $40,000 per year.  The actual amount insurance companies and individuals pay may be less by using rebates and discounts.  Nevertheless, these are expensive medications.

Biologic medicines with FDA approval have increased from nine to 20 between 2009 and 2016.  As new products have become available for sale, experts expected costs of drugs to rise by about one-third between 2009 and 2016,  accounting for inflation and other factors.  Instead, costs rose 144 percent.

The basic law of economics, supply and demand, does not seem to apply here.  With increasing supplies, the cost to the consumer should not have risen this much.  The truth is, cost increases of this magnitude are not unusual in the pharmaceutical marketplace.

Drug Companies, Treatment Guidelines, and Paid Physicians

Why would a group of doctors advise that patients use drugs in a manner contrary to FDA approval? In short, money.

Medical societies and groups who issue treatment guidelines generally receive funding from the same company that markets the drugs addressed in their guidelines.  Doctors who prescribe medications and actually see patients rely on treatment guidelines.  It is a cycle of questionable ethics in which drug companies fund research and encourage medical societies to nudge physicians to use their product.

Think back on the group of dermatologists who issued guidelines for treating psoriasis in 2011.   The guidelines they issued said that a person with a mild form of psoriasis, who had an important upcoming event, would be okay to use biologics to clear it up in the short-term.   However, FDA approval for biologics only extends to more serious cases, specifically moderate-to-severe psoriasis.

The committee that wrote the guidelines contained 15 experts, 12 of whom had financial ties to the company that makes biologics, like those used to treat psoriasis.  Their motives are fairly transparent.

More specifically, the committee chairman who wrote the guidelines disclosed that he received money from three separate companies that make biologics for treating psoriasis.  He received approximately $90,000 from the three companies.

Guideline-writing societies and physicians receive millions of dollars from the companies that manufacture prescription medications.  Conflict of interest is a fairly common occurrence when guideline recommendations involve the use of high-revenue products, such as biologics.

Concerned About Your Medication and FDA Approval?

It is disheartening and certainly unacceptable that pharmaceutical companies prioritize their bottom line over the safety of patients.  If you have questions or concerns about FDA approval and a medication you are taking, contact Drug and Device Watch.

Medical professionals and prescription drug manufacturers have a responsibility to consumers to disclose the full extent of risks associated with their products.  When they fail to do so they can, and should, be responsible.  Learn more about your legal rights as a patient and consumer by contacting Drug and Device Watch.  Call 1-888-458-6825 or contact us online for more information.