Medicine, the Pharmaceutical Industry and Biomedical Research: A Challenging Mix.
(2/2/14)- In a step that is in the right direction towards clearing the opaqueness in connection with drug research, Johnson & Johnson and Yale University announced the signing of an agreement under which the company will share detailed clinical trial study data with the university for J&Jís pharmaceuticals that are already on the market.
All information that might identify a particular patient will be deleted from the data.
Yale will vet proposals from scientists who want to conduct safety; efficacy and other studies of a drug, without input from J & J. ďThe medical scientific community and population at large want to have more transparency on what we do,Ē said Paul Stoffels, J & Jís chief scientist, and world-wide chairman for pharmaceuticals.
All clinical trials now must be registered in advance on the governmentís web-site clinicaltrials.gov, and most medical journal editors will not publish results from unregistered studies. GlaxoSmithKline PLC and Roche Holdings have previously announced similar type agreements.
The data will include individual patient reports and will be far more detailed than the summary papers published in the medical journals.
(12/1/07)- A recent report from the U.S. Senate Finance Committee alleged that GlaxoSmithKline PLC tried to intimidate and stifle John Buse, a diabetes expert and professor of medicine at the University of North Carolina in Chapel Hill because of his critical comments about the company's top selling diabetes drug Avandia.
The report further alleges that Glaxo Chief Executive Jean-Pierre Garnier, and former research chief Tachi Yamada were involved in the intimidation. Dr. Buse began expressing his concern over the drug in 1999 because he felt that the drug exposed the users to excessive cardiovascular risks.
The report went on to state: "a troubling pattern of behavior by pharmaceutical executives" seems to be occurring.
This week the FDA forced the company to add a strong new warning label to Avandia making users aware of the potential heart-attack risks for patients taking the drug. The Senate Finance Committee investigated the matter because it has jurisdiction over Medicare and Medicaid, and therefore should be paying for only safe and effective medications.
The report did not recommend any particular action against the company or its executives.
(12/10/06)- Dr. Steve Galson, the Director of the FDA Center for Drugs stated that the agency projected that there would be 23 new drug approvals done in the year 2006. Of the 23, 17 had been approved by December 1, with an expected 6 being approved by this year's-end. Last year the FDA approved 18 new drugs.
Of the expected 23 drug approvals this year, 13 were standard approvals and 10 were priority approvals. A priority designation sets the target date for FDA action at 6 months.
Priority approvals took a median of 6 months for approval, which is the same time length that they took in 2005. Standard approval median time did however show a marked improvement being accomplished in 13.0 months in 2006 versus the 15.8 month approval time in 2005
(5/15/05)- In recent years, pharmaceutical companies have been running strong direct-to-consumer pitches for specific drugs in the various medias. An article entitled "America Relying More on Prescription Drugs, Report Says" (NY Times Dec. 3, 2004) indicates that "[M]ore than 40% of Americans take at least one prescription drug and 17% take more than three or more drugs". Pharmaceutical companies have shown double digit profits related to specific "blockbuster drugs". For example, Eli Lilly & Company reported that its top-selling schizophrenia drug, Zyprexa, accounts for about half the company's profit. This advertising does an effective job of convincing consumers that they desperately need the advertised product to get well.
Prescription drugs account for 10% of the nationís medical bills, with drug spending growing faster than spending for any other category of medical goods and services. The three largest advertising agencies now "provide services that go from the beginning of drug development all the way to the launch of your products." (J. Abramson, Overdo$ed America p. 110)
Yet, all is not well with the drug industry. Merck announced in late September of 2004 that it would stop selling Vioxx because new studies indicated that the drug "posed cardiovascular risks". Preliminary reports indicate that Merck knew about the potential adverse affect of Vioxx nearly a year before they withdrew the drug from the market (NY Times November 18, 2004, C1, C7, "Earlier Merck Study Indicated Risks of Vioxx".)
Since then, a whole class of medications, the COX-2 inhibitors have come under scrutiny because of studies that have shown high risk for adverse reactions in certain cohort groups of patients. ("Worldwide sales of COX-2 inhibitors totaled $6.7 billion in 2003"-Note in Overdo$ed America, p. 306)
The use of antidepressants in children and adolescents also has also come under careful scrutiny. A year ago, British medical regulators counseled against the use of antidepressant drugs in children because of an increased risk of suicide and suicidal behavior. Health authorities in the United States followed in September 2004, issuing the same caution, but have not withdrawn antidepressant drugs for children or adolescents.
The spin off from the results of these studies has been a plethora of books on medicine and the pharmaceutical industry. A cacophony of public indignation appears to be developing around the pharmaceutical industry. Whether the industry can find safe haven in a port and wait out the storm of challenges to its business practices, only the future will tell. Changes are in the works. Senator Charles E. Greeley (Rep.- Iowa), the chairman of the Senate Finance Committee, and the leader of the hearing into F.D.A.'s oversight of Vioxx, plans to introduce a drug data bill that will require pharmaceutical companies to register all drug trials and report their results in a public database. This registry will allow for more transparency of drug trials, thus preventing companies from hiding unfavorable results.
Not only are the pharmaceutical companies under attack, but also the medical profession itself has come in for its share of criticism. Dr. James Le Fanu's book "The Rise and Fall of Modern Medicine" (Little, Brown, London 1999) provides practical evidence that by 1980 medicine had split into two different directions resulting in researchers losing site of clinical practice methodology.
The medical profession looked toward epidemiological results, with medicine moving into new treatments directed to genetically distinct subgroups of patients and environmental factors at the expense of clinical expertise. This, according to Dr. Le Fanu, gave rise to a new breed of doctors not schooled in basic clinical practice, which he feels is basic to "good" medical practice and curing disease.
Doctors have not learned to listen to their patients. They are becoming medical technocrats, following guidelines, without taking into account who their patients are. Part of this is dictated by the nature of the treatment reimbursement systems that have shortened the time spent with patients.
At the same period of time, medical university administrators viewed their faculties as an undeveloped resource. The Patent and Trademark Amendments Act of 1980 gave universities the right to claim ownership of the research it developed with the use of federal funds. This resulted in a shift in the mission of academia that Sheldon Krimsky ("Science in the Private Interests: Has the Lure of Profits Corrupted Biomedical research?" Rowman and Littlefield 2004) describes as the "privatization of knowledge", with multimillion dollar contracts between the university and industry bringing in needed revenues to meet the financial needs of the university.
Scientists now could become entrepreneurs with political and economic agendas, while providing expert scientific advice and evaluation of new drugs. The needs of industry may have trumped the purity of academic research. This development is now under public and policy scrutiny, even reaching to the Pope in Rome. In March 25, 2002, he wrote the following to the apostolic nuncio in Poland:
"The preeminence of the profit motive in conducting scientific research ultimately means that science is deprived of its epistemological character, according to which its primary goal of discovery of truth. The risk is that when research takes a utilitarian turn, the speculative dimension, which is the inner dynamic of man's intellectual journey, will be diminished".
All this leads us to one final perplexing thought: Why we are the only industrialized nation in the world that is not providing health care coverage to all its citizens?
We are at a critical juncture in our health care system. We need to look beyond the narrow confines of the biomedical commercial paridigm, and provide a high quality of health care for all based on unbiased medical information.
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updated February 2, 2014