Parker Waichman LLP

Drug Company Critics Say Clinical Trials Often Ended Early to Exaggerate Benefits

When drug trials are stopped early, patients in need of such medications benefit; however, pharmaceutical companies could be pressuring researchers to exaggerate a drug’s benefits.  A review of 25 cancer drug trials over 11 years found a trend in trials stopped early once a drug showed a strong benefit.  Critics disagree saying drug benefits can […]

When <"https://www.yourlawyer.com/practice_areas/defective_drugs">drug trials are stopped early, patients in need of such medications benefit; however, pharmaceutical companies could be pressuring researchers to exaggerate a drug’s benefits.  A review of 25 cancer drug trials over 11 years found a trend in trials stopped early once a drug showed a strong benefit.  Critics disagree saying drug benefits can be detected earlier because clinical trials are better designed and that it could be construed as unethical to continue a trial and denying a drug to ill patients.

Giovanni Apolone at the Mario Negri Institute for Pharmacological Research in Milan, Italy, looked at trials conducted between 1997 and 2007 which were stopped after interim data analysis.  Trials analyzed averaged 30 months and over half were stopped within the last three years.  Apolone also identified a trend wherein prematurely halted trials supported drug marketing:  12 were used to support a marketing application; 11 were published in the past three years.  “This suggests a commercial component in stopping trials prematurely,” Apolone says; however, he stresses there is no proof this was any company’s intention.  Apolone’s study did not cover if patients were harmed because of a drugs’ early approval.  Rather, the study focused on if a drug’s benefits could have been exaggerated because the studies examined benefits such as long-term survival.  “If a trial is evaluating the long-term efficacy of a treatment, short-term benefits, no matter how significant statistically, may not justify early stopping,” he said.
An Association of the British Pharmaceutical Industry spokesman said when a trial is stopped early, the regulatory authority is informed.  “Assuming it is for a good reason they will be scrutinising the data especially carefully.  It would not approve the drug unless the data was very robust.  Patient safety is absolutely paramount, so we are not going to take any short cuts.”  Overestimating a drug’s benefit could make it harder to review acceptability of its side effects, says Stuart Pocock at the London School of Hygiene and Tropical Medicine, UK.  “Many cancer drugs are inevitably quite toxic, but I think patients are prepared to risk side effects if they are going to live longer,” adding, “The real problem is if a patient is being exposed to these side effects without getting a clinical benefit.”

According to Karol Sikora, professor of cancer medicine at Imperial College School of Medicine in London, trials might be stopped early because drug benefits are apparent earlier.  “I suspect it is becoming more common because doctors are getting better at spotting which patients should be put into a clinical trial in the first place,” he says.  For example, Herceptin—a breast cancer medication—targets a protein called HER2 and is only found on the surface of some breast cancer cells.  Only those women with breast cancer who tested HER2-positive were given Herceptin during late-stage clinical trials.

Sikora noted independent committees generally scrutinize interim analysis before approving an early trial end.  If they see a benefit, there can be strong ethical arguments to stop a trial saying, “If you didn’t stop the trial, it would mean that people in the control group would miss out.”

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Michelle Josama was absolutely fantastic. Glad we got her for our case. Had a great experience!
Rafael Garcia
5 years ago
5 Star Reviews 150
I want to give a heartfelt thank you to Ms. Benita Rollis for the exemplary manner in which my case was handled from the inception to the end. Ms. Rollis was compassionate, friendly, understanding, professional, accurate, informative and patient. She took the time and effort to explain the process, timeline, the various documents involved and how to go about obtaining certain forms. She was definitely on point. If I had to go this route again, I would hands down, choose and highly recommend Ms. Rollis because she is highly competent in getting the job done. She is a definite asset to Parker Waichman LLP. On behalf of myself and my family we thank you for a job well done. Be well and be blessed. Margarita R. Mitchell
Margarita Mitchell
3 years ago
5 Star Reviews 150
Positive: Professionalism , Responsiveness Benita, was a very helpful person, and acted very professional through our time working with her. She kept us in the loop constantly and answered any questions we had through phone calls and emails in a timely manner. If needed, I would definitely use this company again specifically working with Benita.
Lois Barrera
2 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038