Although this is coveted as a wonderful bill that is needed in the US so that drugs and medical devices can be fast tracked, if you read the nearly 1000 pages it is clear this is dangerous bill that is has the best interests of the Pharmaceutical industry at heart, NOT its consumers.
Courtesy of our allies at Alliance for Natural Health
This time it’s been slipped into a defense bill. Major Action Alert – Send Your Letter Now!
We suspected it would only be a matter of time before Sen. Dick Durbin (D-IL) launched his next broadside against supplements. Once again, Durbin and his allies, including Sen. Richard Blumenthal (D-CT), are pouncing on must-pass legislation and attaching last-minute amendments that would threaten Americans’ access to supplements.
The bill this time is the National Defense Authorization Act (NDAA), an appropriations bill to fund the military for FY 2016. The House passed its version of the bill in May. Sen. John McCain (R-AZ) introduced what is called “an amendment in the nature of a substitute” to create a Senate version of the House-passed bill. The Blumenthal/Durbin amendments were introduced on top of the McCain legislation.
Because it is a defense bill, the Blumenthal/Durbin amendments pertain to the supplement use of the US armed forces.
There are three amendments.
The first amendment would require military electronic health records to include data regarding supplement adverse events experienced by servicemen and women. This type of information is already gathered by the FDA, which is much better situated to handle it than the Department of Defense. This additional data collection is redundant and cumbersome. In 2011, Sen. Durbin and Rep. Henry Waxman (D-CA) asked the Government Accounting Office to review supplement adverse event reports (AERs). In 2013 the GAO completed its report—which overwhelmingly demonstrated that supplements are safe! Why in the world is Durbin following the same tactic that embarrassed him so completely two years ago?
According to the resulting GAO report, there were a total of 6,307 AERs reported to the FDA between 2008 and 2011—an average of 1,575 a year. At the time, we pointed out that this was quite a low number, considering the fact that about half of Americans—157 million people—take supplements. This means that one-hundredth of one percent of all supplement users ever experience any problems at all.
If Sens. Waxman and Durbin had cared to search out where the real danger lies for the American consumer, they wouldn’t have had to look very hard. In 2008 alone, there were a whopping 526,527 AERs for FDA-approved drugs, with 275,421 considered serious. Of course, the astonishingly poor safety record of pharmaceutical drugs is irrelevant if you have a vendetta against supplements, as Sen. Durbin and his allies seem to have.
The second amendment would require the Department of Defense to establish minimum requirements for members of the armed forces to report on their supplement use. Service people would be ordered to report what vitamins and supplements they take—which means they could easily be ordered to stop taking them! It is simply Orwellian to have members of the military report on their supplement use. What business is it of the government if a service member is taking vitamin D, or B12? Big Brother shouldn’t be able to reach into your toiletries kit or control what you tell your doctor—even on a military base.
The third and most troubling of the amendments would extend a currently existing policy which regulates certain supplements on military bases to require all supplements that are to be sold to members of the military at exchange stores or commissaries to undergo a third-party review for “recognized public standards of identity, purity, strength, and composition, and adherence to related process standards.” This may sound innocent, but it is anything but.
First, supplements must already, by law, hold to current good manufacturing practices (CGMPs), which require that that they be processed in a consistent manner and meet quality standards. Second, supplement companies will likely be expected to pay huge sums for this review. Only the biggest companies, many of them owned by Big Pharma, will be able to comply. Yet another government-created monopoly will be handed over to big drug companies.
In addition, once this regime is established, it will be only a short step to expand it to all US consumers, not just the military. Then the pharmaceutical industry will have what it really wants: control over the supplement industry. Many supplements will become drugs and soar in price while their availability is restricted. As with any monopoly, quality will also decline, because regulations are never a substitute for real competition involving new and small as well as old and large companies.
Supplements are incredibly safe and already fully regulated by the FDA and FTC. These amendments are misguided attempts to limit access and hamper individual health freedom.
The truth of the matter is that the current regulatory regime governing dietary supplements is working—which is why supplements have such a sterling safety record. In fact, our counterparts at ANH-Europe found that UK residents were about as likely to get struck by lightning as die from taking dietary supplements.
We’ve come to expect this sort of maneuver from Durbin and company: what can’t be accomplished through more conventional democratic means, they try to accomplish through sneaky, eleventh-hour maneuvering before the public can catch wind of it. This military appropriations bill has nearly 200 amendments attached to it, and not all of them will be discussed by the Senate. With your help, we hope to prevent the Blumenthal/Durbin amendments from ever being considered on the Senate floor. The natural health community has responded vigorously to defeat previous Durbin attacks against supplements: in one instance, our readers sent nearly 90,000 messages in less than twenty-four hours. The time has come again to make our voices heard on Capitol Hill to protect our access to quality dietary supplements!
Major Action Alert! Write or call your senators and urge them to stop the Blumenthal/Durbin amendments, which will take dangerous steps towards limiting consumers’ access to dietary supplements.
by Alison Rose Levy
The Medical Establishment’s “Favorite” Doctor and His Crusade Against Supplements and Alternative Medicine
“People are systematically choosing to manage their own health in a way that is unprecedented,” points out James S. Turner, chairman of Citizens for Health, a health advocacy group with over 100,000 members. “The conventional treatments that Offit champions are often very helpful. The problem is that the industry has oversold them, and more and more people see that now.”
If Offit’s book had aimed to explore all health options even-handedly for their upsides and their downsides, it might have truly advanced the conversation about how to better health and lower healthcare costs. (And ranking below 16 developed nations across the lifespan and for all income levels, while stuck in the midst of a polarized debate over costs and coverage, the U.S. sorely needs that conversation.) But instead, in his book and media tour, Dr. Offit plays the predictable role of debunker, single-mindedly championing his own medical brand. Unfurling an arch skepticism about the use of herbs and other nutritional supplements, for example, Offit presents himself as the stalwart for science. But it’s instructive to see what happens when he encounters someone conversant with the health literature.
An Open Letter to Consumer Reports: 10 Misinformation Hazards in Your “10 Surprising Dangers of Vitamins and Supplements” Article
By James J. Gormley
It is personally disappointing for me that Consumer Reports, the flagship of the respected marketplace-empowerment organization, Consumers Union, has once again seen fit to arm the American consumer with detrimental misinformation regarding safe, beneficial food supplements.
In the alarmist piece which appears in the September 2012 issue, the anti-supplement subtitle reads: “Don’t assume they’re safe because they’re all natural.”
Here are the “10 Surprising Dangers” along with some accurate information and perspective:
“1. Supplements are not risk free.”
With 3,000 deaths and 128,000 hospitalizations a year from food poisoning, it is clear that nothing in life is risk-free, but we already knew this. It would be of better service to do an expose on the dangers of properly prescribed pharmaceuticals, which injure over 1 million and kill over 100,00 Americans each year in hospitals alone. The subtitle on a prescription drugs-focused article could read: “Don’t assume they’re safe because they’re FDA-approved.”
The fact of the matter is that food supplements are inherently benign and pharmaceuticals are inherently dangerous; they are part of a completely different risk paradigm. With the millions of supplements sold and safely used every year, dietary supplements have an enviable consumer safety record.
Since the 1994 enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA), FDA has had the authority to remove any dietary supplement from the market if FDA shows that it presents “a significant or unreasonable risk of illness or injury” or that it contains “a poisonous or deleterious substance which may render it injurious to health.” In fact, the FDA can act immediately against any product that poses an “imminent hazard to public health or safety.” With the passage of the Food Safety Modernization Act (FSMA) in 2011, the FDA’s mandatory recall authority was affirmed and expanded.
Recently released data from risk-management expert Ron Law confirmed that food supplements are by far the safest substances that people are exposed to daily (http://tinyurl.com/ron-law-data).
“2. Some supplements are really prescription drugs.”
Supplements are a class of food, not drugs, so drugs masquerading as supplements is a drug adulteration problem best handled by the Drug Enforcement Administration (DEA), something which I and Citizens for Health have been calling for since early 2010 (http://tinyurl.com/dea-should-take-over), which is now being supported by industry as well (http://tinyurl.com/dea-and-steroids).
“3. You can overdose on vitamins and minerals.”
With only a few exceptions (e.g., iron, selenium, zinc, vitamin A), even with the dosages found in high-potency supplements there is a window of safety on supplements of several hundred percent; in fact, most supplements are so safe that no upper limit can even be determined. What we really have to worry about are the over 13,000 truly dangerous prescription drugs on the market with known side effects.
“4. You can’t depend on warning labels.”
True, but since dietary supplements are inherently benign with a margin of safety a mile wide, there is virtually nothing to warn consumers about. To be conservative, many products carry cautions relating to consumption by children and pregnant/breastfeeding women, but this is more to protect companies from actions stemming from gross misuse.
“5. None are proven to cure major diseases.”
The same can be said for prescription drugs. And even if they did, supplement manufacturers would not be allowed to tell consumers about it. Regardless, supplements are complements to the diet not substitutes for healthy food and physical activity.
“6. Buy with caution from botanicas.”
I would venture to say that apart from cities bordering Mexico, over 99.999% of herbal products are sold through mainstream channels of trade. We could also say “don’t buy prescription pain killers” on the black market or from peddlers in back alleys, but some level of common sense usually prevails.
“7. Heart and cancer protection: not proven.”
The American Heart Association recommends a diet rich in marine-based omega-3s, and the U.S. government has approved health claims for vitamin D and calcium supplementation. In 2005, Harvard researchers estimated that low intake of omega-3s in the U.S. diet accounted for 72,000 to 96,000 deaths from cardiovascular disease. There have been numerous animal studies showing direct cancer prevention with omega-3s and epidemiological studies associating high levels of dietary omega-3s with reduced rates of cancer.
Now Consumer Reports is really reaching. Anybody who tries to dry-swallow any pill can experience a gag reflex, which is not a problem unique to any one class of products.
“9. Some natural products are anything but.”
Most dietary ingredients are analogues of natural extracts; technologists are not standing around with wooden mallets, mortars and pestles. There are only one or two cases where a true synthetic is not as efficacious as a natural source nutrient, and that is with vitamin E.
“10. You may not need supplements at all.”
But we need drugs? For decades the USDA has shown that most of us do not get anywhere near a basic level of vitamins and minerals from the standard American diet, so it would be a rare person indeed who would not stand to benefit from a multivitamin/multimineral supplement at the very least.
Although Consumers Union has a long, and illustrious, track record in advocating for consumers, Consumer Reports appears to have a bug in its bonnet regarding dietary supplements, either that or single-copy newsstand sales soar when “supplements are bad” stories are run.
This is unfortunate, since scare-mongering re safe, well-regulated and effective dietary supplements will, at best, only serve to unfairly cause consumers to wrongly distrust a beneficial class of products and, at worst, drive even more Americans away from responsible self-care into the welcoming arms of drug-happy conventional medicine.
That’s not what I call consumer advocacy.
What forces and interests direct the Food and Drug Administration (FDA) and why is this out-of-control law enforcement agency working so hard to take dietary supplements out of our hands?
These are the central questions explored by Citizens for Health’s very own VP and Senior Policy Advisor, James Gormley, in Health at Gunpoint: The FDA’s Silent War Against Health Freedom, what we at CFH hope you will consider to be a groundbreaking book that brings into clear focus the silent war now being waged by the FDA against all of us: American consumers.
Please view this new video about the book:
The FDA was established in 1906 to protect the U.S. public from misbranded and adulterated foods, drinks and drugs. While the original intent may have been honorable, over the years the execution of this mission has become tainted by lobbyists and money.
In Health at Gunpoint, James Gormley presents a history of both the natural foods movement and of this over-reaching Federal agency and examines how the agency has changed over the years. He then looks at the FDA’s most controversial decisions and the troubling reasons behind them.
Why did the FDA try to shut down the supplements industry by getting most supplements classified as drugs? Why did the FDA drag its feet on folic acid fortification while thousands of babies were born with devastating birth defects? Why did the FDA try to get life stages (such as pregancy and aging) and normal discomforts (such as headaches) classified as diseases? Why are irradiated and genetically-altered foods not labeled as such? Why does the FDA favor synthetic additives and dangerous drugs over natural ingredients and dietary supplements? Why did the FDA propose a guidance that would cripple the health food industry as we know it today?
Today, as in the past, the FDA is poised to make decisions that would have a major impact on the health of all Americans. Health at Gunpoint not only sheds light on what is happening, but also explains what you can do about it.
In many European countries, nutritional supplements are now available by prescription only. If you don’t think harmonization-friendly, anti-consumer, restrictions can be put in place here, you may be in for a rude awakening.
Health at Gunpoint will help prepare you for the coming fight!
Over 30,000 of you – Citizen for Health supporters, all – responded to the call to urge the FDA to revise or scrap the supplement-killing New Dietary Ingredient (NDI) Draft Guidance after we launched our multi-pronged campaign in September 2011.
Together with the outreach efforts of fellow health-freedom groups and the natural products industry, we were able to force the FDA to go back to the drawing board on the NDI Draft Guidance!
According to Natural Products INSIDER, “After close to a year of industry outcry, FDA apparently will issue a revised draft guidance on the topic of new dietary ingredients (NDIs).”
According to news reports, FDA’s Commissioner Margaret Hamburg, Deputy Commissioner Mike Taylor, and Assistant Commissioner Jeanne Ireland met with Sens. Orrin Hatch [R-UT] and Tom Harkin [D-IL] on June 19.
Word on the street is that, as a result of that meeting and the overwhelming outcry from the natural health and wellness community, the FDA will be releasing a revised draft guidance that the agency hopes will provide greater clarity and address concerns that the document is not in line with the intent of the original statute. However, industry observers do not expect a revised draft guidance will be released until after the election.
As mentioned, we began our campaign in September 2011, and shortly thereafter, on October 6th, Citizens for Health submitted its own organizational comments to the FDA in opposition to the NDI Draft Guidance.
In November, we launched a viral petition campaign accompanied by a video re-mastered by Australian truth rapper Jody Lloyd a.k.a. Trillion, electrifying American consumers and setting a new benchmark in grassroots advocacy: 10,000 petition signatures in 10 days!
In fact, over 12,000 of you initially made a commitment to health freedom and Citizens for Health (CFH) by signing your name to that critical petition to stop what would have been a dangerous extension of the FDA’s reach!!! We at CFH (Jim Turner and James Gormley) honored that commitment by meeting with top aides from 11 key U.S. House of Representatives and U.S. Senate offices, providing copies of the petition strengthned by 12,686 citizen activist signatures!
And we didn’t stop there.
Not only did you help us reach past our original goal and amass 25,000 signatures by February 25th – today we have 30,215 petition signatures calling on the FDA to do what is right.
While the FDA has to be watched very carefully as this process unfolds, it is certain that consumers successfully sent the agency a clear, irrefutable message. To borrow some jargon from the world of boxing, we made them “retreat to a neutral corner” for the time being.
While we still maintain the position that a complete withdrawal of the petition is what is needed, mothballing it and massively overhauling may hold some promise.
But only time will tell. In the meantime, you can (very briefly) sit on your high horse AND rest on your laurels! How many people get to do that?!
Stay tuned for updates as we move forward with this historic effort.
Joseph M. Bassett, the co-owner of two Bassett’s Health Food stores and a long time leader in the natural products industry, died on June 6th; he was 79 years old. According to his obituary, Bassett died of complications of a bladder and kidney infection.
He was a U.S. Army veteran who served honorably during the Korean War. Bassett and his wife Patricia started Bassett’s Health Foods in 1969, bringing vitamins and supplements to the Toledo, Ohio area. The retail outlet also offered a range of private label products, with formulas developed by Bassett using his knowledge of nutrition. He was trained and licensed in nutritional and massage therapies.
He was also vigorously involved in supporting consumer access to dietary supplements, actively participating as a member of the National Nutritional Foods Association (NNFA, now the Natural Products Association, or NPA).
During Bassett’s first term as president of NNFA from 1993 to 1995, his leadership was critical in leading efforts to pass the Dietary Supplement Health & Education Act of 1994 (DSHEA), which created a new regulatory paradigm for dietary supplements. During his second term as president, from 1997 to 1999, he continued to champion the industry’s goal of providing clear, substantiated information about the health benefits of supplements to consumers.
He was a founding member of the National Institute of Nutritional Education, president of the Mid-American Health Association, past chairman and current board member of Citizens for Health and a former member of the Board of Governors of the National Health Federation (NHF) and a current member of the NHF Advisory Board.
James Gormley, vice president and senior policy advisor of Citizens for Health (CFH), commented on Bassett’s many achievements:
“In 2010, Loren Israelsen told me that after the 1992 FDA raid of Dr. Jonathan Wright’s Tahoma Clinic for his treating patients with high-dose B vitamins, people began to think: ‘Wow, what are they prepared to do to stop us from taking vitamins.’ And this legitimate fear began to spread like wildfire across the country. On the grassroots side, Joe Bassett and the […] NNFA expanded an early incarnation of CFH in order to mobilize consumers and health-food stores against these threats. Along with Bassett were Jim Golick, Margaret Isely, Bonnie Minsky, Dr. Joan Priestley, Alex Schauss, Craig Winters and many others.”
Gormley added: “After the DHSEA victory, Sen. Orrin Hatch commented: ‘I want to cite the dedicated efforts of Citizens for Health, whose thousands of members have worked tirelessly and unselfishly to make this an informed and successful debate. There is no question in my mind that the work of this citizen army makes today’s victory possible.’”
“And that was a tribute to Joe Bassett, who was the force majeure behind these efforts. In recent years, Joe rejoined the board of Citizens for Health, and he became an inspiration today for a whole new generation of health-freedom activists.”
“Of all of the industry leaders I have met, Joe had the most love for the health-foods movement,” added Gormley.
“When health-freedom advocates would get together, Joe’s eyes would well up in tears out of joy and appreciation for the dedication to health justice and freedom that we all shared. But it was love and appreciation that we all felt back. And that love was for Joe Bassett, one of the greatest generals that grassroots advocacy ever had and one of health-food industry’s most effective, outspoken and powerful modern-day pioneers.”
Alexander Schauss, PhD, FACN, president and CEO of Puyallup, Washington-based AIBMR Life Sciences, Inc., and a co-founder of Citizens for Health, said:
“We have all lost a great spirit in the fight for health freedom. Joe was one of those rare people you meet in life one cannot forget. His spirit and achievements will live on for eternity. He was one of the most dedicated, committed, and supportive members of the natural products community [who] played [a central role] in bringing the industry and consumers together during the critical years of 1992-1994, resulting in the successful passage of DSHEA.”
“What characterized Joe Bassett most during those years was his tireless efforts to stop those who attempted to divide the industry for their own self-serving interests, and argue for the power of unity,” said Schauss. “He believed in the fundamental right of freedom of expression and the right to take care of one’s own health. He raised money to support that effort, never to enrich himself. ”
“As a co-founder of Citizens For Health (CFH) in 1991, and its first Executive Director, I remember when Craig Winters stepped aside as Chair and co-founder of the organization in March of 1992 to let Joe become Chair because Craig recognized Joe’s abilities and determination to bring people together nationwide. This brought several Midwest and East Coast citizen organizations together under one roof.”
“He brought people together to share a common desire to preserve our freedom of expression and the right to take care of their own health,” said Schauss.
“Joseph Bassett made a real difference in all of our lives,” Schauss observed, “and his spirit to protect health freedom will live on for eternity.”
“To lose Joe and just two years ago, Craig Winters, is a difficult blow to bear, as we all worked day and night for the same noble cause, as warriors for health freedom,” added Schauss. “The price of freedom is vigilance, as Joe would often say. He never stopped being vigilant, and hence why passage of DSHEA was only the beginning, not the end.”
“Joe has left an indelible mark on the hearts of many, as well as the entire industry he served so valiantly,” remarked Danny Wells, head of Vacaville, California-based natural products industry consultancy, Danny Wells & Associates.
Jim Turner, chairman of Citizens for Health, said:
“Joe Bassett was an inspiration to all who worked with him especially those of us at Citizens for Health. We will redouble our efforts for health freedom as a tribute to Joe and to his motivational leadership.”
Bassett is survived by his wife; three children, Joseph Jr., Sabrina and Charmaine; seven grandchildren; and three great grandchildren. The Bassett family has asked that in lieu of flowers, donations may be made to Nemenhah Press.
We alerted you on Wednesday, May 23rd, that Sen. Richard Durbin [D-IL] was going to propose an amendment (S.AMDT 2127) to the pending FDA Safety and Innovation Act (S.3187) that was a partial resurrection of his 2011 bill, The Dietary Supplement Labeling Act.
Thanks to the efforts of CFH and its supporters, as well as allies in the health freedom movement, that bill was soundly defeated last year.
We are happy to announce that you did it again! In a vote the day after we alerted you to this threat, the U.S. Senate responded to our collective voice and voted 77 to 20 to table the amendment, removing it from consideration in the overall bill. (The bill moves to a debate in the House of Representatives next week).
Click here to see how the votes broke down.
Tell Your Senators What You Think Of Their Votes! (based on your Zip Code, a thank you or a rebuke letter will be offered to you for submission to your Senators)
While it is always important to take action on issues that are important to us, our families and our health freedoms, it is also extremely important to thank our legislators for doing the right thing (when they listen to their constituents) and to reproach them (respectfully) when they do not—as this is the essence of participatory democracy.
Stay tuned for further calls to action if this amendment is re-inserted on the House side and for other issues (where we we will ask for your support or opposition, as the case may be).
Special thanks to Senator Orrin Hatch [R-UT] who noted in comments on the Senate floor prior to Thursday’s vote that Durbin’s amendment was “based on the misguided presumption that the current regulatory framework for dietary supplements is flawed and that the FDA lacks authority to regulate these products.” Hatch went on to say that the amendment “serves to punish all responsible companies with its overreaching mandates.”
Thousands of members of the natural health community called and wrote Senate offices between yesterday and today, calling on their Senators to oppose an anti-supplement amendment, Amendment No. 2127, from Senator Dick Durbin (D-IL) that would have ridden the coattails of the FDA Safety and Innovation Act (S. 3187), also known as the FDA User Fee bill (S.3187).
And you won!!!
Durbin’s amendment that was defeated today would have created a new law that would have circumvented or ignored: the guidelines outlined even in the fatally flawed NDI Draft Guidance; the facility registration rules already in place under the Bioterrorism Act of 2001; and the over 35,000 product labels already on file with the FDA and the US National Library of Medicine.
The failed amendment would have been a product registration nightmare creating burdensome and unnecessary registration of all safe dietary supplements, moving supplement labeling submission requirements that much closer to drug-like regulations that we see in Canada and Europe today.
Tens of thousands of products would have had to be removed from store shelves in order to be made compliant with new, completely unwarranted 30-day post-market product and label registration requirements.
This legislation was defeated today via a motion to table the amendment by supplements champion Senator Tom Harkin (D-Iowa) and Senator Orrin Hatch (R-Utah).
Our thanks to both Senators and to all of you!!
Our victory today reminds us of how important our health freedoms are, and how extra-vigilant we need to be every day.
The price of freedom is eternal vigilance!
By James J. Gormley and Frank Herd, Jr.
Starting at 2:00 p.m. today, May 24th, the Senate will vote on 17 amendments to the Food and Drug Administration Safety and Innovation Act (S. 3187) – also known as the FDA User Fee bill (S.3187) – followed by a vote on final passage, including anti-supplement Amendment No. 2127 from Senator Dick Durbin [D-IL].
Sound familiar? It should – you helped us defeat this move last year when an expanded version of it appeared as S. 1310, Durbin’s Dietary Supplement Labeling Act of 2011. Please use the link below to call your Senators right away and urge them to oppose Durbin’s amendment when it’s introduced, and to focus instead on holding unscrupulous food companies accountable to our existing system of consumer protections.
Last year’s S. 1310 was a misguided response to marketing tactics by unscrupulous food companies trying to circumvent FDA standards – and so is Sen. Durbin’s Amendment No. 2127 to be voted on today.
This amendment would create a totally new law!
That’s right, a new law that would circumvent: the guidelines outlined even in the fatally flawed NDI Draft Guidance; the facility registration rules already in place under the Bioterrorism Act of 2001; and the over 35,000 product labels already on file with the FDA and the US National Library of Medicine.
The product registration nightmare of this new law would require burdensome and unnecessary registration of all safe dietary supplements, moving supplement labeling submission requirements that much closer to drug-like regulations that we see in Canada and Europe today.
Tens of thousands of products would have too be removed from store shelves in order to comply with new, completely unwarranted 30-day post market product and label registration requirements!!
Leave a voicemail, or a message with an aide saying that you have learned that there will be a vote today on Senator Durbin’s amendment to S. 3187, one that unfairly targets makers of dietary supplements and that your Senator should oppose it.
Please also ask your Senator to focus instead on holding accountable the duplicitous companies looking to circumvent existing regulations.
Keep an eye on your email box and on www.citizens.org for updates as this issue develops.