Drug companies and the FDA: an illegitimate marriage that could kill you

Drug companies and the FDA: an illegitimate marriage that could kill you

The Lancet has thrown down the gauntlet and gone in the face of the FDA with a blast I never thought I would see in the best scientific medical journal in the world. The title of the editorial reads: “Lotronex and the FDA: A Fatal Erosion of Integrity”-a sensational indictment from a true pillar of medical science.

The article gets right down to business. In the scathing report, Lancet editor Richard Horton relates the case of Lotronex–which has been prescribed extensively for irritable bowel syndrome (IBS). IBS is an inconvenient, uncomfortable disease but it is not life threatening. Keep this fact in mind as you read this shocking story of greed, stupidity, conspiracy, and betrayal.

After the deaths of five patients using the drug, the manufacturer-GlaxoSmithKline-voluntarily withdrew Lotronex from the market in November 2000. Now senior FDA officials are seeking to reintroduce it. Why would they do such an incongruous thing, in the face of five deaths from the drug? Horton says it’s because the FDA has become a “servant of the drug industry.”

You can’t make it much plainer than that, and that is only the beginning of Horton’s indictment of the FDA. He goes on to accuse FDA officials of excluding scientists within the FDA who raised safety concerns from any further involvement with the drug, its safety, and its future.

Besides the five deaths, there were other horrific reports- including 49 cases of ischemic colitis and 21 cases of severe constipation that involved instances of obstructed and ruptured bowels. These are serious life-threatening complications.

Thirty-four patients required admission to the hospital, and 10 of those required surgery.

When patient records first confirmed “substantial and potentially life-threatening risks,” the FDA didn’t bother pulling Lotronex off the market. No, it merely issued a “medication guide.” Seven patients had serious, life-threatening complications, and the FDA reacted as though the patients had developed a benign skin rash.

The FDA’s fatal decision

The “medication guide” was a sick joke. FDA scientists, not the FDA politicians, knew that advising patients to stop taking Lotronex if they felt “increasing abdominal discomfort” was dangerous and irresponsible, since abdominal pain is also a primary symptom of IBS-the disease Lotronex is supposed to treat. How is the patient (or the doctor) to know whether to stop the drug because of side effects or to increase the dose to treat the disease? It’s a case of the blind leading the blind. This is junk medicine, bordering on quackery.

“This story reveals,” said Horton, “not only dangerous failings in a single drug’s approval and review process but also the extent to which the FDA, its Center for Drug Evaluation and Research (CDER) in particular, has become the servant of industry.” He added that the FDA receives hundreds of millions of dollars of funding from the pharmaceutical industry.

The FDA scientists, although under severe pressure to keep their mouths shut, did finally take a stand, and, in a report last November, said, “Early warning of the dire side effects of this drug is clearly not feasible.” They added that “a risk-management plan cannot be successful.”

When questioned by Reuters News, Martin Sutton, a spokesman for GlaxoSmithKline, said: “Both the FDA and ourselves are trying to find a resolution that will benefit and protect patients.” That’s fine, Martin, but there is a very easy “resolution.” KEEP THIS DANGEROUS DRUG OFF THE MARKET.

I said above that IBS is not a life-threatening disease and so should not be treated with life-threatening drugs. Horton confirmed my opinion on IBS to Reuters News, saying that “irritable bowel syndrome may be extremely unpleasant but is not life-threatening to approve a drug that can lead to ruptured bowel and death is at odds with the normal balance between risk and benefit.”

In order to break the “tightening grip of big pharma,” as Horton dubs it, certain restrictions must be placed on the illegitimate marriage uniting the FDA, the drug industry, and the medical journals. One of Horton’s primary demands is that covert private communications between FDA officials and industry stop immediately. And, he says, the FDA should welcome, not censure, differences of opinion within the organization.

Medical journals: FDA accomplices

Horton’s editorial stresses the sins of the FDA without addressing the issue of the compromised medical journals. They are equally guilty of deceit in the publication of research reports.

The Washington Post published a report in early August that is basically an admission by the world’s best medical journals that they have indeed been sinning against their physician readers and blatantly trashing the Hippocratic oath.

Standing in the medical police lineup, hats in hand, are the crme de la crme of scientific medical publishing: the New England Journal of Medicine, the Lancet, the Annals of Internal Medicine, and the Journal of the American Medical Association. In a highly unusual phenomenon, and probably a science publishing first, it was announced that these and other lesser journals would publish “a joint editorial” in September explaining how the medical publishing community is going to mend its ways.

I have been flailing away at the journals and insulting them at every opportunity for 20 years with no visible effect. It took the Lancet, the only journal with clean hands, to drive them to near panic and the forthcoming mea culpa. Their response, from what I have heard of it, is rather flabby and half measure. The only way for them to regain the confidence of the medical community is to go cold turkey and refuse pharmaceutical advertising. But they’re too addicted to the swag, and so they will not go cold turkey, or even warm turkey-after all, money talks, truth walks.

One final note on the Horton editorial in the Lancet: Dr. Horton has demanded some important reforms to bring the FDA to heel. But he left out the most vital change needed: ABOLISH THE FDA. It is too corrupt for repair.

Horton, Richard. “Lotronex and the FDA: A Fatal Erosion of Integrity,” Lancet, 357: 1,544

Woodman, Richard. “Update: Lancet Says FDA Far Too Cozy With Drug Industry,” Reuters Health, 5/18/01

Susan Okie. “A Stand for Scientific Independence,” Washington Post, 8/5/01