THE FDA’S DELIBERATE GROSS NEGLIGENCE IN APPROVING ADHD DRUGS

ADHD drugs are dangerous controlled substances which can destroy lives, as the DEA has been warning for decades. This is why the DEA continues to keep these substances in Schedule II in the same abuse potential category as cocaine or methamphetamine (https://www.dea.gov/druginfo/ds.shtml). This being so, one would assume that the FDA must have extensively researched and validated their safety prior to approving their lifelong use for ADHD children as young as three. But this is far from what has actually occurred, as was determined by the 2014 study “Premarket Safety and Efficacy Studies for ADHD Medications in Children” published in the peer-reviewed journal PLOS One. (http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0102249) These researchers state:

A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. … We sought to identify and evaluate all safety and efficacy trials submitted to the FDA for the approval of ADHD drugs and quantify the number of participants studied and their length of exposure prior to the market availability of each ADHD medicine.

The researchers determined:

These drugs are intended for chronic use in children, but the median trial length prior to approval is 4 weeks and only 3 of the drugs have been assessed in long-term safety trials. … Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy.

The researchers explain how the FDA failed to follow the ICH’s guidelines which provide “specific recommendations on the safety assessment of chronic drugs used in the treatment of non-life-threatening conditions, which includes ADHD.” These guidelines were not binding but nevertheless designed to guide the clinical trial practice of the FDA.

This study has determined:

Seven drugs [including Adderall, Ritalin and Dexedrine] were approved by the FDA for the treatment of ADHD without the submission of any clinical trial data by the sponsors [Table 2 displays zero under the column titled ‘Number and Type of Clinical Trials’ for these drugs]. … Ritalin, the oldest drug approved for ADHD, was approved based on prior clinical experience, which was presented as a bibliography. Methylin was a new formulation of previously approved methylphenidate that underwent an NDA but without the submission of pediatric efficacy trials. [15] Desoxyn was originally approved in 1943 as an anorectic in the treatment of obesity but no clinical trials assessing its safety in children or its efficacy in the treatment of ADHD in children were identified in the original approval package. The indication for ADHD is first included on the drug label in 1965 without supporting clinical trials [this drug is methamphetamine, a common drug of abuse] in the accompanying documentation. The approval package for Cylert includes information on pre-clinical trials without mention of clinical trials conducted for any indication. Dexedrine was approved for the treatment of narcolepsy, obesity, and ADHD, but the approval package does not include trials enrolling children or studying efficacy for ADHD. Similarly, Biphetamine was previously approved as an anorectic in adults, but the original approval package does not include safety assessments in children and ADHD was added as an indication in product labels starting in 1979 without supporting clinical trials. Adderall [the most common ADHD drug] was originally approved in 1960 as an anorectic under the trade name Obetrol before being marketed without FDA approval as Adderall for the treatment of ADHD. Approval was subsequently obtained without clinical trials assessing its safety in children or efficacy in ADHD[16].

It is interesting to note that no trials were required to market Adderall to children despite the fact that this same medication had previously been recalled when it was called Obetrol prescribed for obesity. (http://www.nytimes.com/1973/04/02/archives/us-sets-diet-drug-recall-in-drive-on-amphetamines-us-to-begin-diet.html) This drug was recalled in 1973 before the invention of ADHD which allowed it to re-enter the market under a different disguise in the absence of safety and efficacy trials justifying its approval.

The FDA’s deliberate inadequacy in ensuring the safety of ADHD drugs (pre and post approval) unfortunately does not end here. The same study states:

FDA approval of 4 of the drugs included required submission of additional clinical trials [post-approval] by the sponsor and 2 drug approvals included recommendations for additional trials (Table 4). The basis for the required studies cited by the FDA included concerns over limited long-term safety data, limited study in the adolescent population, and insufficient information on specific potential adverse events [17]–[19].

Regarding such post-marketing surveillance studies required or recommended for assessing long-term safety, the researchers expalin:

In the U.S., the FDA historically relied on studies referred to as “post-marketing commitments” to obtain additional safety and efficacy data after a drug was approved. [34] These commitments were agreed upon by the FDA and the pharmaceutical companies at the time of approval and were often mandated as a condition for approval. However, the FDA lacked any avenues for enforcement, and reports showed that as many as two-thirds of requested studies were never started by the pharmaceutical companies. [35], [36] The FDA Amendments Act of 2007 granted the FDA additional authority to require post-marketing studies–now referred to as “post-marketing requirements”–and also expanded the conditions under which the FDA could make the requests. [37] The FDA may now take enforcement action to ensure studies are conducted

But the FDA has never enforced the completion of 2 of its required 4 studies, violating the Amendments Act of 2007. The 2014 study further states:

The sponsors for Daytrana and Kapvay [less common ADHD drugs] conducted the required studies, adhering to the timelines imposed by the FDA for study completion. None of the studies required for Vyvanse or Intuniv [more common ADHD drugs with a much larger market share than Daytrana and Kapvay] or any of the studies recommended for Ritalin or Focalin XR [also quite popular drugs with a large marker share] could be identified. The corresponding pharmaceutical companies in each of these cases were contacted and were also not able to provide us with information that these trials had been conducted.

What might have motivated the FDA to approve the lifelong use of controlled substances for even toddlers without requiring long-term studies to invalidate the DEA’s conclusion about the dangers of these substances derived from real-life data? How could this approval process have gone through without requiring extensive long-term studies in the absence of legitimate objective diagnostic methods verifying the chemical deficiencies claimed to necessitate such risky drugs (see pdf file #1), without bothering to follow the guidelines created for properly conducting FDA trials, without even bothering to enforce the completion of the long-term studies originally required? The answer is best described in papers such as the one published in 2007 in the New England Journal of Medicine, titled “Paying for Drug Approvals — Who”s Using Whom?” published . (http://www.nejm.org/doi/full/10.1056/NEJMp078041) This paper explains:

User [industry] fees now account for more than 40% of the budget of the FDA division that reviews new drug applications. … Colleagues at the FDA have told me of a worrisome side effect of PDUFA [The Prescription Drug User Fee Act]: the growing sense that the organization is accountable to the industry it regulates. One FDA scientist who was often criticized for being too concerned about drug-risk data was told by his supervisor to remember that the agency’s client was the pharmaceutical industry…

In February 2007, a Congressional Hearing was held questioning the adequacy of the FDA to assure the safety of the nation’s drug supply.(https://www.gpo.gov/fdsys/pkg/CHRG-110hhrg35502/html/CHRG-110hhrg35502.htm) At this Congressional Hearing, Senator Grassley reported a number of problems with the FDA, which he later summarized as follows:

I’ve identified problems at the FDA that consistently fit into a few themes.

First, scientific dissent is discouraged, quashed, and sometimes muzzled inside the Food and Drug Administration. Second, the FDA’s relationship with drug makers is too cozy. The FDA worries about smoothing things over with industry much more than it should with its regulatory responsibilities. Third, inside the FDA there’s widespread fear of retaliation for speaking up about problems. And fourth, the public safety would be better served if the agency was more transparent and forthcoming about drug safety and drug risks.(https://www.finance.senate.gov/ranking-members-news/-senator-grassleys-testimony-to-house-oversight-hearing-on-the-adequacy-of-fda-efforts-to-assure-the-safety-of-the-drug-supply)

In the light of all these facts, one can only conclude that the FDA did not conduct or enforce long-term trials and approved its riskiest (previously recalled) ADHD drug Adderall in the utter absence of pre and post approval trials, due to a combination of its fear of the outcomes of these trials as well as the existing knowledge of the long-term life-ruining effects of Schedule II stimulants. Verifying the obvious would have prevented the agency from serving to raise the profits of its wealthiest “clients”.

I have additional evidence of the FDA’s drug company affiliations which have led to countless additional abhorrent acts and gross negligence, all of which would make a book in itself. You can find some of it here: http://adhddrugslongterm.com/fda-corruption/

Leave a Reply

Your email address will not be published. Required fields are marked *