Six Drugs the FDA Doesn't Want You to Know Relied on Tainted Data
In 2011, the Food and Drug Administration determined that a major laboratory, the Houston facility of the now-defunct Cetero Research firm, had committed such "egregious" and pervasive research violations that years of its tests were potentially worthless. About 100 drugs were affected, but the FDA has declined to name them, saying to do so would reveal confidential commercial information. ProPublica was able to pinpoint six drugs whose approval rested, at least in part, upon data from the Cetero studies. Related Story »
| Temodar IV Injection |
Torisel Injection |
Lazanda Nasal spray |
Generic Ibuprofen Gelatin Capsules |
Generic Tramadol Extended-release capsules |
Generic Hydrocodone polistirex/ chlorpheniramine polistirex Liquid |
|
| Generic Name | Temozolomide |
Temsirolimus |
Fentanyl |
|||
| Other names | Temodal (in Europe) |
Torisel |
PecFent (in Europe) |
|||
| Drug Company | Merck & Co |
Pfizer Inc. |
Archimedes Pharma |
Banner Pharmacaps |
Cipher Pharmaceuticals |
Tris Pharma |
| What it is | A chemotherapy drug aimed at difficult-to-treat brain cancers |
A drug used to treat renal cell carcinoma, a type of kidney cancer |
An extremely potent painkiller |
A popular over-the-counter painkiller |
A powerful painkiller |
A narcotic cough suppressant and anti-allergy medication |
| What we Know about Cetero's Role |
Cetero Houston analyzed the "pivotal" trial that formed the basis for the intravenous drug's approval in the United States. The data from the trial appears on the product's label, as well as in the peer-reviewed publication stemming from this trial. |
Cetero analyzed a component of a study to test the drug's effect on heart rhythms. Cetero's role was small – it analyzed blood samples of certain patients – but the study was an important one that the FDA had required of the company. |
Cetero analyzed a clinical trial that tested how the drug behaved when paired with a decongestant. All of the information on the drug label having to do with decongestant interactions came from this trial, which also shows up in court records and was used for FDA approval. |
Cetero analyzed one of the trials to establish the capsule's equivalence to other forms of the drug. |
Cetero performed three clinical trials meant to prove the drug's equivalence to the name-brand version. The product label has detailed information about the rate at which the drug enters the bloodstream, gleaned from these trials. FDA approval also relied in part on these trials. |
Cetero analyzed both of the clinical trials used to show that the generic was equivalent to the name brand -- a key requirement for FDA approval. |
| Company's Explanation | Merck spokesman Ronald Rodgers stated that Merck has full confidence in the data on the drug's label and that the intravenous formulation "remains an important option" for patients who can't swallow capsules. |
Pfizer spokesperson Chris Loder said the Cetero measurements provide only "indirect support" to the main thrust of the study, and don't undermine the overall conclusion. |
Archimedes Chief Development Officer Michael Perelman said that although the company did not redo the trial, it is confident in the product and its label. "We conducted an analysis. Our conclusion is that the data from Cetero is valid," he said. |
Banner spokesperson Jennifer Almond said the company "repeated the subject bioequivalence study at another clinical research organization" and filed the paperwork with the FDA. |
Cipher CEO Larry Andrews said the company has more data on the drug – performed by an independent laboratory – that is further evidence of safety. "I have all the confidence in the world there are no issues with regard to our product." |
Tris Pharmaceuticals' Director of Regulatory Affairs, Scott Groner, said that when Tris hired a consultant to audit the data from the trials, "they came back 100 percent clean." |
| FDA Response | FDA declined to comment, claiming that a response would jeopardize commercial confidential information. |
FDA declined to comment. |
FDA declined to comment. |
According to the FDA, Banner submitted a new bioequivalence study in January 2012, which the FDA found acceptable. |
FDA declined to comment. |
According to an FDA spokesperson, the agency had reviewed the audit and found it “acceptable.“ |