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Alert Number 224
Date: March 28, 2024
The darn thing about human nature: everywhere you turn, there it is.
Should doctors be obliged to report if they get large amounts of money from drug companies? How about “recruitment fees” for getting their patients to sign up for clinical trials conducted by drug companies with huge vested interests? How much of a conflict of interest is there in doctors who recommend specific clinical trials to their patients, if they are going to benefit from it personally or professionally? Would you dare to ask your doctor whether he has financial ties to the drug company whose trial he is recommending to you? Would he be offended if you did?
Recruitment bias in clinical trials is a huge problem. There are only so many CLL patients that are willing and able to participate in clinical trials. It is well understood that clinical trials conducted by not-for-profit organizations and governmental agencies such as the NIH have a hard time competing with mega clinical trials run by drug companies. When all is said and done, the clinical trials that go forward are not the ones with the greatest scientific merit. Most often they are the ones with most money supporting them, the ones that are likely to make the most money for their corporate sponsors. Clinical trials conducted by corporate sponsors are several times more likely to find benefit in the drugs they are testing, compared to similar trials conducted by organizations with no vested money interest in the research. When you have a big hammer, everything looks like a nail – that is only human nature, right?
Should experts with financial ties to the drug company in question be allowed to testify before FDA, pushing for approval of the particular drug in question? “Bias” is not always an indication of corruption. Heck, I am biased. I think my daughter is the prettiest girl in town, my dog is smarter than any other mutt and I will defend to the hilt my right to hold those opinions. But bias in scientists is a far different beast. Objectivity, scrupulous attention to details, intellectual honesty and dedication to searching for the truth – these are the hallmarks of a good scientist. When clinical science is subverted to serve the needs of personal or professional advancement, when corporate greed or professional hubris get in the way of accurate reporting of results, guess who pays for this subversion of the process? That’s right, you guessed it right, it is us chickens. We pay for it as taxpayers, and we pay for it again as patients fighting the fight of our lives.
Even for the majority of patients who would never consider participating in a clinical trial, this is a hugely important issue. If truth is relative, if science gets subverted and statistical results get “sliced and diced” until the conclusions suit corporate interest, we all pay the price. “Gold Standards” are not what they seem if the system is not transparent, the only gold is in the stock prices of the companies skating ever closer to the line. I agree: the capitalist system is necessary to get things moving. But we also need checks and balances; we need watchdogs who will bark loud; we need oversight and consumer protection. I am glad to see these issues are being discussed once more, after too many years of silence. I hope you browse the two Reuters articles below.
Be well,
Chaya
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News Reports:
Disclosure Laws Do Not Fully Reveal Drug Company Payments to Physicians
Reuters Health Information 2024. © 2024 Reuters Ltd.
NEW YORK (Reuters Health) Mar 20 - Laws that mandate disclosure of payments to physicians by pharmaceutical companies provide limited public information, according to a new report.
At present, five states and the District of Columbia have legislation requiring payment disclosure. Among these states, Minnesota and Vermont require that the information be made available to the public.
In the current study, reported in the March 21st issue of the Journal of the American Medical Association, Dr. Joseph S. Ross, from Mount Sinai School of Medicine in New York, and colleagues examined the accessibility and quality of information provided by the disclosure laws in Minnesota and Vermont.
The analysis included data from January 2024 to December 2024 in Minnesota and from July 2024 to June 2024 in Vermont.
The researchers found that obtaining the payment information was not easy. In Vermont, extensive negotiation with the Office of the Attorney General was needed, while in Minnesota, manual photocopying of individual disclosure forms at the State Board of Pharmacy was required.
Missing disclosure information was common in both states.
In Vermont, 61% of payments were not released to the public because the drug companies classified them as revealing trade secrets and 75% of disclosed payments lacked information to identify the recipient.
In Minnesota, just 25% of drug companies reported payment information in all three years of the study.
Quite large payments to physicians were commonplace, the report indicates. In Vermont, 2416 of the 12,227 payments studied were each at least $100, amounting to a total of $1.01 million; the range was $100 - $20,000 and the median payment was $177. In Minnesota, such payments were even more common: 6238 of 6946 payments were at least $100 (ranging up to $922,239, with a median payment of $1000), and these amounted to $22.39 million.
In a related editorial, Dr. Troyen A. Brennan, from Aetna Inc. in Hartford, Connecticut, and Michelle A. Mello, from Harvard School of Public Health in Boston, comment that pharmaceutical companies' "primary commitment is to create shareholder value, not maintain an altruistic commitment to patients. But at some point the leadership of the pharmaceutical industry and their board of directors must begin to recognize that growing public and professional mistrust could substantially detract from that value."
JAMA 2024;297:1216-1223,1255-1257.
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FDA Says Plan Limits Advisers' Industry Ties
Reuters Health Information 2024. © 2024 Reuters Ltd.
By Lisa Richwine
WASHINGTON (Reuters) Mar 22 - Doctors and scientists with industry ties exceeding $50,000 a year would be banned in most cases from sitting on influential Food and Drug Administration advisory committees under guidelines released on Wednesday.
The proposal is meant to tighten limits on which outside experts can serve on the panels and minimize conflicts of interest, FDA officials said.
"We think this will help us better fill advisory committees with the scientific expertise that we need in a manner that preserves public confidence in the integrity of our process," Randall Lutter, the FDA's acting deputy commissioner for policy, told reporters.
Financial links between the panel members and drug makers have come under scrutiny in recent years, prompting calls for the FDA to find advisers without industry connections.
The committees provide recommendations on whether new drugs or medical devices should be approved, as well as on other issues. The FDA is not required to follow the panels' advice but it usually does.
Under the agency's new plan, financial ties would include stock ownership or payments for research and consulting from companies that could be affected by a panel decision. An expert generally would be disqualified if the combined value exceeded $50,000 for the past 12 months, the FDA said.
For smaller sums, an expert may be allowed to take part in committee discussions but could not vote on recommendations.
The FDA commissioner could make an exception to the guidelines and allow participation. Lutter said he expected exemptions to be rare.
Rep. Maurice Hinchey, a New York Democrat who has pushed legislation to rid advisory panels of financial conflicts, welcomed the FDA move. "The leadership at the FDA is now acting in the public interest," he said in a statement.
But a consumer group said the $50,000 limit was too high because smaller amounts could sway an individual.
"A drug (representative) who takes someone to a memorable restaurant twice a year to chat about new drug developments is spending relatively little money but is building a relationship that is likely to be more influential than giving a $2,000 honorarium -- perhaps even more than a $50,000 grant for a study funded by several companies," said Diana Zuckerman, president of the National Research Center for Women & Families.
The FDA will take public comments on the proposal for 60 days before issuing final guidelines.
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